Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Wounds and Injuries

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Acute Lung Injury

Lung Injury

Transfusion-Related Acute Lung Injury

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Transfusion Reaction

Hematologic Diseases

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

During the Control cohort period patients will have study data collected following transfusion with only conventional PCs for up to 21 days of transfusion support, as clinically indicated in a manner that is consistent with the local standard of care.

During the INTERCEPT phase, patients will receive only INTERCEPT PCs and will have study data collected following transfusion for up to 21 days of transfusion support, as clinically indicated in a manner that is consistent with the local standard of care.

Standard of Care

Edward L Snyder, MD

This study is a prospective, non-randomized sequential cohort, open label, multi-center, non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The patient population will be hematology-oncology patients, including those undergoing hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.

For each participating center, the study will start with a brief pilot run-in period with a group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot run-in is to evaluate study logistics and data collection methods within each study center. Data from the pilot phase will be included in the data analysis for the treatment comparison.

After the pilot run-in period, the study will be conducted in two sequential patient cohorts: 1) the Control cohort during which study patients will receive only conventional PCs, and 2) the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient enrollment at each Center will be monitored to target similar numbers of patients into the Control and Test Cohorts within each center. Centers may enroll Control and Test patients in ratios that vary from 2:1 to 1:2 due to institutional requirements to move rapidly to full INTERCEPT implementation, or due to availability issues with either Test or Control components. Within each Center, patient enrollment will be stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3) non-myeloablative conditioning, and (4) reduced intensity using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. Note time from last chemotherapy treatment to first study transfusion should be no more than 30 days. To ensure both Test and Control cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen strata, enrollment caps will be set for the Test cohorts, hence no Test patients will be enrolled to a stratum once the cap for the given stratum is met. Eligible patients will be enrolled in open Test strata sequentially as long as there is sufficient Test PC inventory available. Enrollment may be delayed for the Test cohort if sufficient inventory of Test PCs is not available.

The study will have a pilot run-in period and two sequential cohort groups for each center.

Pilot Run-in Period The pilot run-in period will be conducted in each center with a group of at least 5 patients exposed only to conventional PCs, who provide informed consent for data collection. The purpose of this pilot run-in is to evaluate study logistics and data collection methods within each study center. Data collection will not differ from that required in the two sequential patient cohorts. The data from the pilot phase will be included in the data analysis for the treatment comparisons.

Control and INTERCEPT Cohorts Following the run-in period, the study will be conducted in two sequential cohort periods. Informed consent for data collection without study specific treatment intervention, and under patient confidentiality, will be required for both cohorts prior to any study procedure.

During the Control cohort period, patients will have study data collected following transfusion with only conventional PCs for up to 21 days of transfusion support, as clinically indicated in a manner that is consistent with the local standard of care. During the INTERCEPT phase, patients will receive only INTERCEPT PCs under the same clinical treatment guideline. Patients will be transfused with only study PCs of the assigned treatment type (Conventional or INTERCEPT) in each cohort. Patients enrolled in the Conventional control cohort will be excluded from participating in the study in the INTERCEPT cohort.

Enrollment will be stratified by study center and type of primary disease therapy (chemotherapy only or HSCT with myeloablative, non-myeloablative, or reduced intensity conditioning).

For both cohorts, patients will be supported with study PC transfusions for a maximum of 21 days or until platelet transfusion independence. Patients are considered to have achieved platelet transfusion independence if more than 5 days elapse after exposure to a study PC transfusion. When a patient achieves platelet independence, the patient will have completed the study PC transfusion period (even if they subsequently resume another cycle of platelet support).

For the pilot phase and both cohort periods, all baseline O2 saturation values if available in the medical record should be recorded on eCRF. O2 measures associated with any form of respiratory therapy (except for room air ventilation) should be recorded with the indicated respiratory therapy for each day of therapy. If multiple measures are available in the medical record on a single day, then the worst value will be recorded.

Data collection for all participants will comprise: patient baseline disease characteristics, including primary disease, type of HSCT (auto, allo, cord blood, matched related or matched unrelated) or type of chemotherapy, and medications at study entry and during the study observation period. Patient clinical respiratory status, including, if available, a chest imaging study at baseline and O2 saturation by non-invasive pulse oximetry if available in the medical record prior to the first study transfusion in each cohort period, will also be recorded.

Within each study cohort, patients will be assessed for the primary outcome measure of assisted ventilation for a maximum of 28 days (7 days surveillance following up to of 21 days of study PC transfusion support). Patients with assisted ventilation within the defined timeframe will be further assessed for ARDS using the Berlin criteria by both the Investigator (based on diagnoses documented in the medical record) and the Pulmonary Adjudication Panel. Furthermore, AEs (including TR) will be collected from the primary medical record for 24 hours following the initiation of each study PC transfusion.; SAEs (including ARDS), CSPAEs (Grade 2 or higher AEs affecting the Respiratory System) and mortality will be collected for 7 days post each study transfusion (or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner). Investigators will assess the intensity of each AE and SAE and provide their assessment of the relationship of each AE and SAE to the study transfusion. Patients who experience the outcome of assisted ventilation, ARDS, or CSPAEs will be assessed as detailed in Assessment of Pulmonary Adverse Events in the synopsis and in Protocol Section 8.1.

For patients who achieve platelet independence before Study Day 21, AEs will be collected for 24 hours after initiating the last study platelet transfusion prior to platelet independence; the outcome of assisted ventilation, SAEs, ARDS, CSPAEs, and mortality will be collected for 7 days after the last study PC transfusion prior to platelet independence (or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner).

For patients who require more than 21 days of PC transfusion support, AEs will be recorded for up to 24 hours after the initiation of the last platelet transfusion up to and including Day 21; the outcome of assisted ventilation, SAEs, ARDS, CSPAEs, and mortality will be collected for up to a maximum of 28 days (7 days after up to 21 days of platelet transfusion support),7 days after initiating the last study transfusion within the 21-day study transfusion period (or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner). The lowest daily O2 saturation values in the medical record will be recorded on the eCRF as well.

Study-specific research personnel will review the patient medical record and record study outcomes on electronic Case Report Forms (eCRF). The intensity of AEs and SAEs will be graded according to the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE) classification system. TR will also be assessed following the CDC National Healthcare Safety Network (NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol (NHSN Protocol).

A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

A Prospective, Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

For the purposes of this study, assisted mechanical ventilation defined as assisted ventilation started after the initiation of the first study PC and can be administered either by intubation or tight fitting mask with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP or BiPAP) ≥ 5 cm H2O, if PEEP or CPAP information is available. Assisted mechanical ventilation is selected as the primary outcome as it provides an objective measure of severe, clinically significant pulmonary injury. Patients will be assessed for the initiation of assisted ventilation within 7 days after each study PC transfusion.

Time from first study Platelet Component transfusion to onset of treatment-emergent assisted mechanical ventilation.

Adverse Events occurring within 24 hours after the initiation of a study PC transfusion.

Transfusion Reactions occurring within 24 hours after the initiation of a study PC transfusion.

Serious Adverse Events occurring within 7 days after each study PC transfusion

Acute Respiratory Distress Syndrome occurring within 7 days after each study PC transfusion

Clinically Serious Pulmonary Adverse Events occurring within 7 days after each study PC transfusion

Mortality within 7 days after the last study PC transfusion, or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner (all deaths and deaths due to ARDS).

Cerus Corporation

Heart and Blood Diseases

Thromboembolism

Venous Thromboembolism

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Chris E Holmes, MD

David J Schneider, MD

Chris Holmes, MD, PhD

Chris Holmes, MD PhD

Thrombosis is common and contributes significantly to morbidity and mortality in patients with cancer. At least 20% of patients with cancer develop venous thromboembolism (VTE) and another 5% will experience acute arterial thromboembolism (ATE) due to cancer and its treatment. Current guidelines recommend VTE thromboprophylaxis in high-risk outpatients. Thromboprophylaxis strategies are inadequate as 50% of high-risk patients on prophylaxis still develop a VTE, the rate of recurrent VTE is \~24% with a case fatality rate of 14.8%, and the incidence of major bleeding is \~13% with a case fatality rate of 8.9%. We and others have implicated platelets in both the pathogenesis of VTE as well as cancer growth and metastasis. To investigate a new biomarker of risk in patients with cancer, we propose a pilot study to determine whether quantification of platelet FcɣRIIa expression can discriminate risk of VTE and cancer progression. We chose platelet FcɣRIIa expression because we have found that quantifying platelet surface expression of FcγRIIa identifies patients at high and low risk of thrombotic arterial events. Thus, we hypothesize that elevated platelet expression of FcγRIIa will identify patients with cancer who are greater risk of VTE as well as cancer progression. The proposed studies leverage a clinical research program that was established in 2015 at the University of Vermont Cancer Center (Venous Thromboembolism Prevention in the Ambulatory Care Clinic \[VTEPACC\]) and will allow simultaneous access to research samples, thrombosis complications and cancer outcomes in order to achieve the following specific aims: 1) To determine whether platelet expression of FcγRIIa identifies cancer patients at high and low risk of VTE, and 2) To determine whether increased platelet expression of FcγRIIa is associated with a) advanced stage cancer at the time of enrollment and b) greater progression of cancer. Platelet reactivity is increased in patients with cancer and has been associated with VTE risk. Platelet expression of FcγRIIa can increase the risk of thrombosis by both increasing platelet reactivity and by promoting the procoagulant potential of platelets. In addition, platelets promote cancer by facilitating tumor vascularization, growth, and metastasis. FcγRIIa has been shown to be a key mediator of platelet secretion and cross-talk between platelets and tumor cells. Thus, we propose that increased platelet FcγRIIa expression will be linked to enhanced tumor growth and metastasis by facilitating cancer-tumor cell cross-talk and thereby the activation of platelets that leads to the release of platelet products. Identification of a biomarker capable of discriminating high and low risk of VTE will provide an important precision tool that could be combined with existing tools to guide therapy and improve outcomes. Results from aim 2 will provide key preliminary data in support of novel antiplatelet treatments to limit cancer progression.

Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer

University of Vermont

Professor of Medicine

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Anti-Infective Agents

Clopidogrel

Aspirin

Trichostatin A

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Purinergic P2Y Receptor Antagonists

Neurotransmitter Agents

Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.

Plavix

Katherine N Weilbaecher, M.D.

The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.

A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients

The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients

Measured by number of patients who have detectable circulating tumor cells

Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.

Percent of patients with a given number/range of CTCs ( 0, 1-5 \>+ 5) vs. time baseline 2-weeks and 1 month for plavix \& Aspirin arm and observation only

Mean platelet inhibition vs. time plotted for Plavix \& Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).

Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups

Barnes-Jewish Hospital

Washington University School of Medicine

Plavix and Aspirin

Observation Only

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The number of participants with detectable CTCs (\>= 1 CTC) was calculated at baseline.

The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline

Some breast cancers have high amounts of a protein called HER2/neu on the surface of the cancer cells (called HER2/neu-positive (HER2-positive) breast cancer). The HER2/neu protein is important for cancer cell growth.

Human Epidermal Growth Factor Receptor 2 Positivity (HER2+)

Estrogen Receptor + means that the breast cancer is considered "hormone-receptor-positive."

Estrogen Receptor Positivity (ER+)

≥3

Number of Metastatic Sites

Number of Previous Metastatic Chemotherapy Regimens

≥2

Number of Previous Metastatic Endocrine Therapies

Number of Participants Concurrently using Trastuzumab

Number of Participants Concurrently using Bisphosphonate

Number of Participants who Smoke

Inclusion of patients with no or few CTC's limited ability to distinguish anti-platelet therapeutic effect.

Early termination because of low probability of reaching statistical significance for primary outcome

Katherine Weilbacher, M.D,

Plavix \& Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.

Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs

Bleeding (possibly related)

Back pain (unlikely related)

Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting

Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug

Baseline 0 CTCs

2 week 0 CTCs

1 month 0 CTCs

Baseline 1-5 CTCs

2 weeks 1-5 CTCs

1 month 1-5 CTCs

Baseline >=5 CTS

2 weeks >=5 CTCs

1 month >=5 CTCs

Denominator for Plavix \& Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23

Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time

Baseline Aspirin Reaction UnitsARU

2 weeks ARU

1 month ARU

Denominator for Plavix \& Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23

Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups

Baseline

2 weeks

1 month

Mean Platelet inhibition Denominator for Plavix \& Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23

Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups

Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.

Plavix

This trial was terminated early due to futility, subjects were not followed for progression free-survival.

Progression Free Survival

Overall Study

Thrombocytopenia

Blood Platelet Disorders

Cytopenia

Antineoplastic Agents

Oprelvekin

Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg).

Only for Dose-finding in Phase Ⅲa.

Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg).

Only for Dose-finding in Phase Ⅲa.

Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg).

Only in Phase Ⅲb.

Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）.

Only in Phase Ⅲb.

mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；

NL201

mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；

The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.

rhIL-11

This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.

The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.

A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11

Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.

Beijing Northland Biotech. Co., Ltd.

Symptoms and General Pathology

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Bone Marrow Diseases

Precancerous Conditions

Patients allocated to the therapeutic platelet transfusion group will not receive routine prophylactic platelet transfusions.

Patients allocated to the prophylactic platelet transfusions will receive a platelet transfusion (a single dose of random donor platelets (4 unit pool or random donor platelets or one apheresis unit) when the measured platelet count is \< 10 x 109/L.

Patients allocated to the therapeutic platelet transfusion group will not receive routine prophylactic platelet transfusions. Platelet transfusions will be given to treat documented clinically relevant bleeding defined as WHO bleeding of grade 2 or greater. Patients may be transfused at the discretion of the treating physician. The indication for all platelet transfusions will be recorded by asking the ordering physician.

Patients allocated to the prophylactic platelet transfusions will receive a platelet transfusion when the measured platelet count is \< 10 x 109/L. Patients may receive additional platelet transfusions at the discretion of the treating physician. The indication for all platelet transfusions will be recorded.

Platelet Transfusion

Alan Tinmouth, MD, MSc

As a result of the underlying disease or its therapy, it is common for patients with blood cancers to have low platelet counts. While platelet transfusions may be beneficial in preventing or treating bleeding symptoms, in circumstances where the risk of bleeding is low they may be unnecessary or even harmful. As a blood product, transfusion of platelets may be associated with infectious or allergic complications, and frequent hospital visits for transfusion may adversely affect quality of life. Additionally, the potentially overuse of platelet products places a burden on health care resources.

The benefit of the current practice of prophylactic platelet transfusions to prevent hemorrhage is unknown. The randomized data that exists is more than 25 years old and not informative given methodological limitations and the changing standards of supportive care. An alternative, therapeutic, strategy involves only administering platelets to control active bleeding.

The standard of practice in inpatients receiving high dose chemotherapy (either for acute leukemia or as part of stem cell transplantation) is prophylactic platelet transfusions. In outpatients not receiving high dose chemotherapy, the risk of bleeding is significantly lower. No randomized trials have examined the optimal platelet transfusion strategy in outpatients with blood cancers undergoing supportive or palliative therapy. Thus the potential benefit of prophylactic transfusions in the outpatient setting is unknown.

The investigators propose to perform a pilot randomized controlled trial to determine if a larger trial is possible. The ultimate goal is to determine if a strategy of therapeutic platelet transfusions is safe and effective in outpatients with blood cancers and low platelet counts.

Randomization:

A local study nurse will use a web-based randomization system (permuted random blocks of two or four patients) to allocate consenting patients. Medical and research staff and investigators will be blinded to randomization scheme.

Study Duration and Follow-up:

All patients will be assigned to either a therapeutic or prophylactic platelet transfusion for a 6-month period. This period of time will allow us to assess our primary feasibility outcomes of enrollment, compliance with transfusion protocols, and completion of bleeding evaluations and quality of life questionnaires by patients.

Patients in both groups will have their CBC measured at least weekly while on study. More frequent monitoring of the platelet count may be performed at the discretion of the treating physician. The research team will clinically assess patients within 1 week (+/- 3 days) of randomization, and monthly thereafter. Patients will be asked to report any non-cutaneous grade 2 or greater bleeding immediately to their treating physicians and the study team. All the self-assessments of bleeding will be reviewed at each patient visit to ensure that all clinically relevant bleeding episodes have been captured.

Patients whose platelet count recovers to greater than 20 x 109/L for at least six weeks will be taken off the weekly platelet count monitoring as reflects clinical practice. They will continue to be monitored for the duration of the study. If their platelet count falls to 10 x 109/L or below then they will be restarted on the monitoring and previous transfusion protocol.

Data Collection:

Baseline Data - The following clinical and laboratory data will be collected at the time of enrolment: (1) demographic data, (2) diagnosis including date and disease stage, (3) prior chemotherapy, (4) ECOG performance status, (5) comorbidites, (6) previous platelet and red cell transfusions, (7) red cell transfusion history, (8) prior bleeding events, (9) quality of life (EQ5D) (10) routine bloodwork

Transfusions:

All platelet and red cell transfusions will be recorded including date and number of units. For platelet transfusions, the type of platelet product (e.g. apheresis or buffy coat) and ABO compatibility will recorded. Additionally, the indication for all transfusions (prophylactic or to treat bleeding) will be obtained from the attending physician.

Bleeding Assessment:

Participants will be asked to complete a simple bleeding questionnaire on a daily basis which has been previously tested and used in outpatients with thrombocytopenia. Patients will receive a short training session and written material on how to complete the form. A bleeding assessment will be performed at all study follow-up visits (interview, physical exam and review of daily bleeding forms). Bleeding events will be assigned a bleeding grade by the study personnel. A final bleeding grade will be assigned by an adjudication panel of 2 blinded physicians who will independently assign bleeding scores. Any discrepancies in bleeding scores will be resolved by consensus.

Quality of Life:

Quality of life will be measured using the EQ-5D. The EQ-5D is a validated tool for measurement of health-related quality of life there is a precedent for its use in transfusion medicine trials. Quality of life assessments will be performed at baseline and at all subsequent patient visits.

Outpatient Platelet Transfusions in Myelodysplastic Syndromes and Leukemia: The OPTIMAL Pilot

Overall enrollment, off protocol transfusions per each randomized group, total number of platelet transfusions per group and patient compliance with daily self assessment of bleeding will be evaluated.

Assessments will include:

1. Non-cutaneous Grade 2 bleeding or higher by the World Heath Organization (WHO) bleeding assessment scale 28(Appendix B)
2. Grade 3 bleeding or higher
3. Time from randomization to first bleeding event of grade 3 of higher
4. Total number of red cell transfusion per group
5. Total number of hospital days per group
6. Number of completed daily bleeding assessments per group
7. Quality of life
8. Mortality

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components	NCT02549222	Transfusion Rel...	Standard of Car...	-	Cerus Corporation
Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer	NCT05240508	Venous Thromboe...		18 Years -	University of Vermont
Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer	NCT05240508	Venous Thromboe...		18 Years -	University of Vermont
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients	NCT00263211	Breast Neoplasm...	Plavix Aspirin	18 Years -	Washington University School of Medicine
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11	NCT01663441	Chemotherapy-in...	NL201 NL201 NL201 rhIL-11	18 Years - 75 Years	Beijing Northland Biotech. Co., Ltd.
Outpatient Platelet Transfusions in Myelodysplastic Syndromes and Leukemia: The OPTIMAL Pilot	NCT01615146	Myelodysplastic... Leukemia	Platelet Transf...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for platelet

Every month we try and update this database with for platelet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for platelet

Every month we try and update this database with for platelet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for platelet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.