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

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Respiration Disorders

Premature Birth

Infant, Premature, Diseases

Infant, Newborn, Diseases

Respiratory Distress Syndrome, Infant

Pharmaceutical Solutions

All Drugs and Chemicals

Plasma-lyte 148

Participants receive Mesenchymal Stem Cells (MSCs) for adult respiratory distress syndrome (ARDS).

Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.

Mesenchymal Stem Cells (MSCs)

Amanda L. Olson, MD

The goal of this clinical research study is to learn about the safety of giving mesenchymal stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells can help control ARDS when given with drugs that are routinely used to treat ARDS.

In this study, participants will receive 1 infusion of MSCs.

This is an investigational study. MSC infusions for the treatment of ARDS is investigational.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

The MSCs:

MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs used in this study were collected from healthy donors and are stored and grown in a laboratory at MD Anderson. The product you will receive is from a healthy donor that is not related to you.

MSC Administration:

If you are found to be eligible to take part in this study, you will receive MSCs by vein over about 1-2 hours 1 time on Day 1.

Study Visits:

On Days 1 and 3:

* Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.
* Blood (about ½ teaspoon) will be drawn to check the oxygen level in your blood.

On Days 14 and 30:

°Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.

On Days 30 and 60:

°You will be checked for possible reactions to your treatment, including graft-versus-host disease (GVHD - a reaction of the donor's immune cells against your body). This will be checked by physical exam, by the doctor reviewing your side effects, and blood from standard of care blood draws.

Length of Study:

Your participation on this study will end after the Day 60 study visit. You will be taken off study early if you are not able to receive the MSC infusion(s), if intolerable side effects occur, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.

Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies

A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies

Adverse Events determined by CTCAE version 4.

Clinical improvement defined as decreased mechanical ventilation after the mesenchymal stem cell (MSC) infusion.

An improvement in PF or S/F ratio defined as decreased mechanical ventilatory requirement.

Katz Foundation

M.D. Anderson Cancer Center

Infections

Neoplasms

Skin and Connective Tissue Diseases

COVID-19

Ganglion Cysts

Synovial Cyst

Cysts

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Antihypertensive Agents

Analgesics

Anesthetics

Dexamethasone

Bupivacaine

Anesthetics, Local

Dexamethasone acetate

BB 1101

Clonidine

Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.

An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.

Stellate Ganglion Block

This study will establish the safety and efficacy of using stellate ganglion blocks in patients with ARDS due to COVID-19 disease.

The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative equipment will be immediately available. A norepinephrine solution will be at bedside to treat potential hypotension associated with SGB. The SGB perineural catheter will be placed using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2% bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue infusion and remove the catheter after 5 days.

Open-label use of stellate ganglion block.

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
Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies	NCT02804945	Blood And Marro... Adult Respirato...	Mesenchymal Ste...	18 Years -	M.D. Anderson Cancer Center
Stellate Ganglion Blockade in COVID-19 Positive Patients	NCT04445337	COVID 19 ARDS	Stellate Gangli...	19 Years - 85 Years	University of Nebraska

Spots Global Cancer Trial Database for ards

Every month we try and update this database with for ards 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 ards

Every month we try and update this database with for ards 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 ards 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.