NCT03806556

A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Meghan McCormick · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pediatric Cancer
• Thrombocytopenia
• Hemostatic Disorder
• Coagulation Defect; Acquired

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	IV medication administered after patient meets inclusion/exclusion criteria
DRUG	Normal saline	IV medication administered after patient meets inclusion/exclusion criteria

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2019-01-16
• Last updated: 2021-09-20
• Results posted: 2021-09-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study