Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Hemorrhage

Hemostatic Disorders

Blood Coagulation Disorders

Blood Loss, Surgical

Intraoperative Complications

Hematologic Diseases

Vascular Diseases

Hemorrhagic Disorders

Coagulants

All Drugs and Chemicals

Hemostatics

Thrombin

Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.

Treatment of significant blood loss conventionally, ie. using massive transfusion protocol if necessary, clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma (Clauss method).

ROTEM-guided protocol of hemostatic resuscitation

Rotational thromboelastometry

Clinical judgement and conventional coagulation tests

Conventional treatment

Anne Kuitunen, MD, PhD

Need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. Allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant tumor, although the detailed mechanism of this effect is still under debate. We plan to evaluate whether a new, rotational thromboelastography-guided algorithm (ROTEM) to guide hemostatic resuscitation intra-operatively decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. 60 patients having a potentially curative pancreaticoduodenectomy (or resection of cauda of pancreas), total removal or partial resection of kidney and open radical cystectomy are recruited when an active blood loss of more than 1500 ml is estimated and/or measured and are randomized into two groups: one will be treated conventionally, ie. using massive transfusion protocol (MTP) if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm.

60 patients having a potentially curative abdomino-oncological surgery and reaching an active blood loss of more than 1500 ml are randomized into two groups. One will be treated conventionally, ie. using MTP if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm. Randomization (ratio 1:1 in blocks of 10) between the two groups will be done beforehand. Each paper containing the treatment protocol in question will be put into a closed envelope. The envelopes are numbered from 1 to 60 and are placed in a box in the operative department.

Participants do not know which group he/she is randomized into. They are under general anaesthesia, thus not knowing which protocol is used. When assessing outcomes, two groups are labeled only by number: the assessor does not know which arm is number 1 or 2 until whole data is analyzed.

ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery

ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery

Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm

Red blood cell units transfused per patient during operation or up to 24 hours after beginning of surgery

Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery

Number of days patient is in hospital immediately after surgery

Any side-effect considered or suspected originating from blood product transfusion

Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event

Tampere University Hospital

Thrombocytopenia

Blood Platelet Disorders

Cytopenia

Fibrinolytic Agents

Tranexamic Acid

Antifibrinolytic Agents

Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).

Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.

IV medication administered after patient meets inclusion/exclusion criteria

Normal saline

Meghan McCormick, MD

This study evaluates the use of tranexamic acid (TXA) in addition to standard therapy in children receiving chemotherapy or blood and/or marrow transplantation to decrease the risk of bleeding. Half of participants will receive tranexamic acid and half of participants will receive placebo.

The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the safety and feasibility of the addition of antifibrinolytic therapy with tranexamic acid to the standard care in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy in order to prevent bleeding. The results of this study will change practice by providing evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to platelet transfusion therapy in the thrombocytopenic patient.

This trial is designed as a prospective, randomized, controlled, blinded (patient, caregiver, physician, assessor) trial with two parallel groups and a primary endpoint of feasibility and safety. Randomization will be performed as block randomization with a 1:1 allocation within blocks of size four.

The investigational pharmacy will be notified when patients enroll on trial. When participants meet criteria for randomization, this will be completed by the Investigational Pharmacy. The pharmacy will prepare and distribute to floor nursing staff all doses of tranexamic acid (available in IV form as a colorless liquid) or placebo (as an equal volume of normal saline). Labels will not carry identifiers of which study arm the enrolled patient is on.

A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia

Anonymized public data set will be available after publication of primary results

Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.

The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.

Number of participants eligible for study enrollment and recruited.

The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.

Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).

Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug

Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).

Any venous or arterial thrombosis on standard diagnostic imaging post-randomization

Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug

Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).

Meghan McCormick

Principal Investigator, Fellow

Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).

Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria

Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.

Normal saline: IV medication administered after patient meets inclusion/exclusion criteria

Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Diagnosis

Type of Therapy

The pre-specified analysis described in the study protocol stated the following: "For secondary endpoints, events of WHO Grade 2 or higher bleeding will be compared through the use of odds ratio or T-test statistic of means. The mean number of platelet transfusions will be analyzed using a T-test statistic of means." This analysis was not completed as it would be scientifically inappropriate due to insufficient enrollment. Instead a descriptive analysis was completed.

Meghan McCormick, MD MS

Grade 3 Adverse Events : Anemia

Grade 3 Adverse Events : Anorexia

Grade 3 Adverse Events : Bone Pain

Grade 3 Adverse Events : Catheter Related Infection

Grade 3 Adverse Events : Vomiting

Grade 3 Adverse Events : Febrile Neutropenia

Grade 3 Adverse Events : Fever

Grade 3 Adverse Events : Hypoalbuminemia

Grade 3 Adverse Events : Hypotension

Grade 3 Adverse Events : Hypoxia

Grade 3 Adverse Events : Hypophosphatemia

Grade 3 Adverse Events : Rash Maculo-Papular

Grade 3 Adverse Events : Nausea

Grade 3 Adverse Events : Mucositis Oral

Grade 3 Adverse Events : Sinusitis

Grade 3 Adverse Events : Skin Infection

Grade 3 Adverse Events : White Blood Cell Decreases

Grade 3 Adverse Events : Platelet Count Decreased

Grade 3 Adverse Events : Blood Bilirubin Increased

Grade 4 Adverse Events : Anemia

Grade 4 Adverse Events : Anorexia

Grade 4 Adverse Events : Bone Pain

Grade 4 Adverse Events : Catheter Related Infection

Grade 4 Adverse Events : Vomiting

Grade 4 Adverse Events : Febrile Neutropenia

Grade 4 Adverse Events : Fever

Grade 4 Adverse Events : Hypoalbuminemia

Grade 4 Adverse Events : Hypotension

Grade 4 Adverse Events : Hypoxia

Grade 4 Adverse Events : Hypophosphatemia

Grade 4 Adverse Events : Rash Maculo-Papular

Grade 4 Adverse Events : Nausea

Grade 4 Adverse Events : Mucositis Oral

Grade 4 Adverse Events : Sinusitis

Grade 4 Adverse Events : Skin Infection

Grade 4 Adverse Events : White Blood Cell Decreases

Grade 4 Adverse Events : Platelet Count Decreased

Grade 4 Adverse Events : Blood Bilirubin Increased

Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03

Assessed for Eligibility

Screened for Complete Inclusion/Exclusion Criteria

Eligible for Enrollment

Consented to Participate

All patients assessed for eligibility as defined by diagnosis of hematologic or solid tumor malignancy and anticipated platelet counts ≤20,000/uL for ≥5 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery	NCT03993977	Blood Loss, Sur... Blood Loss Requ... Coagulation Def...	Rotational thro... Conventional tr...	18 Years -	Tampere University Hospital
A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia	NCT03806556	Pediatric Cance... Thrombocytopeni... Hemostatic Diso... Coagulation Def...	Tranexamic Acid Normal saline	2 Years - 21 Years	University of Pittsburgh

Spots Global Cancer Trial Database for coagulation defect; acquired