Clinical trial NCT02578901: American Trial Using Tranexamic Acid in Thrombocytopenia
Official title: American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombocytopenia
Keywords: Thrombocytopenia
Tranexamic Acid
TXA
Chemotherapy induced thrombocytopenia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-10-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria (all must be met):

* 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)

Exclusion criteria (none can be present):

* 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)
* Subjects on dialysis
* Subjects with creatinine ≥5.7mg/dL
* Subjects who are pregnant or nursing or unwilling to use contraception during and for 30 days after taking the study drug (both males and females)
* Subjects enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
* Known allergy to tranexamic acid
* Having been previously randomized in this study at any stage of their treatment
* Subjects who are unwilling to accept blood or blood component transfusions

Primary outcomes:
measure: Bleeding Within 30 Days
timeFrame: 30 days after activation of study drug
Secondary outcomes:
measure: Number of Platelet Transfusions
timeFrame: 30 days after activation of study drug
measure: Number of Days Alive and Without WHO Grade 2 Bleeding
timeFrame: during the first 30 days post activation of study drug
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Terry Gernsheimer, MD
role: PRINCIPAL_INVESTIGATOR
References: