American Trial Using Tranexamic Acid in Thrombocytopenia

Phase 3

Completed

• Conditions: Thrombocytopenia
• Interventions: Drug: Placebo; Drug: Tranexamic Acid

• Registration Number: NCT02578901
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.

Detailed Description

The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. 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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2016-06
• Primary Completion: 2020-03
• Study Completion: 2020-06-11
• Status Verified: 2021-02
• Results First Submitted: 2021-02-26
• Results First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Results First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Tranexamic Acid (TXA)	Tranexamic Acid	IV or PO administered after meeting inclusion/exclusion criteria

Primary Outcome Measures

Name	Time	Method
Bleeding Within 30 Days	30 days after activation of study drug	Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.

Secondary Outcome Measures

Name	Time	Method
Number of Days Alive and Without WHO Grade 2 Bleeding	during the first 30 days post 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
Number of Platelet Transfusions	30 days after activation of study drug	Number of platelet transfusions per patient during the first 30 days post prescription activation of study drug

Trial Locations

Locations (3)

University of Washington; 🇺🇸 Seattle, Washington, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States