American Trial Using Tranexamic Acid in Thrombocytopenia

NCT02578901 | Completed Phase 3 Results DMC

• 2 other identifiers: STUDY000033291U01HL122272-01A1
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 3

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.

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia; Tranexamic Acid; TXA; Chemotherapy induced thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Bleeding Within 30 Days

  Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.

  30 days after activation of study drug

Secondary Outcomes (2)

• Number of Platelet Transfusions

  30 days after activation of study drug

• Number of Days Alive and Without WHO Grade 2 Bleeding

  during the first 30 days post activation of study drug

Study Arms (2)

Tranexamic Acid (TXA)

ACTIVE COMPARATOR

IV or PO administered after meeting inclusion/exclusion criteria

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered

Also known as: TXA

Tranexamic Acid (TXA)

Placebo DRUG

Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered

Also known as: NS

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 18 years of age
• Confirmed diagnosis of a hematologic malignancy or aplasia
• Undergoing or planned chemotherapy, immunotherapy, or hematopoietic stem cell transplantation
• Anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤ 10,000/microliters for ≥ 5 days
• Able to provide informed consent and comply with treatment and monitoring, or having a Legally Authorized Representative (LAR)

You may not qualify if:

• Diagnosis of acute promyelocytic leukemia undergoing induction chemotherapy
• History of ITP, TTP or HUS
• Subjects receiving L-asparaginase as part of their current cycle of treatment
• Subjects with a past history or current diagnosis of arterial or venous thromboembolic disease including acute coronary syndrome, peripheral vascular disease and retinal arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
• Subjects with a diagnosis/previous history of sinusoidal obstruction syndrome (also called veno-occlusive disease)
• Subjects receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) and/or an antifibrinolytic agent within 48 hours of enrollment, or with known hypercoagulable state
• Known inherited or acquired bleeding disorder including, but not limited to:
• Acquired storage pool deficiency
• Paraproteinemia with platelet inhibition
• Known inherited or acquired prothrombotic disorders, including antiphospholipid syndrome. Those with lupus anticoagulant or positive antiphospholipid serology without thrombosis are not excluded.
• Subjects receiving anticoagulant therapy or anti-platelet therapy (except when receiving prophylactic anticoagulant or low dose aspirin therapy for prophylaxis only with a plan to discontinue when the platelet count falls below 50,000)
• Patients with DIC according to the patient's physician
• Subjects with WHO Grade 2 bleeding or greater within 48 hours prior to activation
• Subjects requiring a platelet transfusion threshold \> 10,000/microliters at time of randomization
• Subjects with anuria (defined as urine output \< 10mls/hr over 24 hours)

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

University of North Carolina

Chapel Hill, North Carolina, 21599, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Poston JN, Brown SP, Ilich A, Ginsburg AS, Herren H, El Kassar N, Jensen CE, Triulzi DJ, Key NS, May S, Gernsheimer TB. Fewer severe infections with tranexamic acid in patients with hematologic malignancies. Res Pract Thromb Haemost. 2024 Mar 1;8(2):102358. doi: 10.1016/j.rpth.2024.102358. eCollection 2024 Feb.

  PMID: 38666065 DERIVED

• Ilich A, Gernsheimer TB, Triulzi DJ, Herren H, Brown SP, Holle LA, Lucas AT, de Laat B, El Kassar N, Wolberg AS, May S, Key NS. Absence of hyperfibrinolysis may explain lack of efficacy of tranexamic acid in hypoproliferative thrombocytopenia. Blood Adv. 2023 Mar 28;7(6):900-908. doi: 10.1182/bloodadvances.2022008255.

  PMID: 36044391 DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Susanne May
• Organization: University of Washington

sjmay@uw.edu

206-685-1302

Study Officials

• Terry Gernsheimer, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Biostatistics

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: June 11, 2020
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Public use data will be available within 3 years after primary outcome completion. These will be available through NHLBI and the duration of their availability will be according to NHLBI biolincc protocols.
• Access Criteria: The access criteria will be according to NHLBI biolincc protocols at the time of the request.

Locations

US (3)