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Trial record 37 of 419 for:    TRANEXAMIC ACID

A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT03806556
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Meghan McCormick, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Thrombocytopenia Hemostatic Disorder Coagulation Defect; Acquired Drug: Tranexamic Acid Drug: Normal saline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
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).
Drug: Tranexamic Acid
IV medication administered after patient meets inclusion/exclusion criteria
Other Name: TXA

Placebo Comparator: Placebo
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.
Drug: Normal saline
IV medication administered after patient meets inclusion/exclusion criteria
Other Name: NS




Primary Outcome Measures :
  1. 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 [ Time Frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug ]
    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.

  2. Feasibility of tranexamic acid as an adjunct to standard therapy: Number of participants eligible and recruited [ Time Frame: From time of recruitment of the first patient until the last patient is enrolled, up to 18 months in duration ]
    Number of participants eligible for study enrollment and recruited


Secondary Outcome Measures :
  1. World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding [ Time Frame: 30 days after activation of study drug ]
    Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug

  2. Number of platelet and red blood cell transfusions [ Time Frame: 30 days after activation of study drug ]
    Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug

  3. Number of days alive and without WHO grade 2 bleeding or greater [ Time Frame: 30 days after 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

  4. The Occurrence of thromboembolic adverse events and serious adverse events [ Time Frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug ]
    Any venous or arterial thrombosis on standard diagnostic imaging post-randomization

  5. Bleeding of any Grade [ Time Frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug ]
    Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug

  6. Highest observed grade of bleeding (as measured on WHO bleeding scale) during the study period [ Time Frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug ]
    Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a confirmed diagnosis of hematologic malignancy or solid tumor malignancy
  • Patients must be undergoing or planned chemotherapy or BMT
  • Patients will only be eligible to receive study drug or placebo during inpatient periods
  • Patients must be predicted to have thrombocytopenia ≤20,000/microliter (uL) for ≥5 days
  • Patient must have a platelet transfusion threshold of ≤10,000/uL (for hematologic or solid tumor malignancies who are not undergoing BMT) or ≤20,000/uL (for patients with hematologic or solid tumor malignancies who are undergoing BMT)
  • Patients must be >14 days beyond their last dose of Pegylated(PEG)-Asparaginase or Erwinia
  • Patients must be able to comply with treatment and monitoring

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL)
  • History of Immune Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS)
  • Diagnosis of Disseminated Intravascular Coagulopathy (DIC)
  • History of inherited or acquired bleeding disorder AND/OR inherited or acquired prothrombotic disorder
  • Patient must not have WHO Grade 2 bleeding or greater within 48 hours prior to enrollment or study drug activation
  • Patient must not have received PEG-Asparaginase or Erwinia Asparaginase within the 7 day period prior to enrollment. If one of these products is given within the 8-14 day period prior to enrollment patients are eligible if prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR) and fibrinogen are obtained and are within 1.5 times the upper limits of normal.
  • Patient must not be receiving tranexamic acid or other anti-fibrinolytic agent or any other agent to promote hemostasis (which includes DDAVP, recombinant Factor VII, Prothrombin Complex Concentrate, Estrogen Derivatives and Progestins)
  • Patient must not be receiving therapy with anticoagulation or antiplatelet therapy (which includes heparin infusion, enoxaparin, aspirin. If anticoagulant/antiplatelet therapy is discontinued when platelet count is <50,000/uL patient will be eligible for enrollment)
  • Patient must not be receiving platelet growth factors
  • Current/prior history of thromboembolic event
  • Current/prior history of sinusoidal obstruction disease
  • Visible hematuria
  • Renal dysfunction (as defined by age-specific creatinine values calculated by Schwartz equation) or hemodialysis or anuria (defined as <10 mL urine/hour over 24 hours)
  • History of seizures
  • Allergy to tranexamic acid
  • Pregnancy
  • Unwilling to accept blood product transfusions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806556


Contacts
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Contact: Meghan McCormick, MD 412-692-5720 meghan.mccormick3@chp.edu
Contact: Darrell Triulzi, MD 412-209-7304 triudj@upmc.edu

Locations
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United States, Pennsylvania
UPMC Childrens Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Meghan McCormick, MD    201-919-6793    meghan.mccormick3@chp.edu   
Contact: Darrell Triulzi, MD    4122097304    triudj@upmc.edu   
Principal Investigator: Meghan McCormick, MD         
Principal Investigator: Darrell Triulzi, MD         
Sponsors and Collaborators
Triulzi, Darrell, MD
Investigators
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Principal Investigator: Meghan McCormick, MD UPMC Childrens Hospital of Pittsburgh

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Responsible Party: Meghan McCormick, Principal Investigator, Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03806556     History of Changes
Other Study ID Numbers: PRO18100519
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized public data set will be available after publication of primary results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Beginning within 1 year and ending 5 years after trial completion
Access Criteria: Researchers who provide a methodologically sound proposal may request data. Proposals should be directed to meghan.mccormick3@chp.edu. To gain access data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meghan McCormick, University of Pittsburgh:
tranexamic acid
anti-fibrinolytic agents
chemotherapy-induced thrombocytopenia
Additional relevant MeSH terms:
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Tranexamic Acid
Hemostatic Disorders
Thrombocytopenia
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants