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Trial record 3 of 37 for:    AMINOCAPROIC ACID

PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid) (PROBLEMA)

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ClinicalTrials.gov Identifier: NCT02074436
Recruitment Status : Recruiting
First Posted : February 28, 2014
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ana G. Antun, MD, Emory University

Brief Summary:

STUDY BACKGROUND AND PURPOSE:

Patients with hematological malignancies (blood-related cancers) often develop thrombocytopenia (low platelet count), which can be made worse by cancer treatment.

Preventive (prophylactic) platelet transfusion remains the standard of care for thrombocytopenic patients. However, bleeding remains a significant problem in these patients, affecting approximately 20% of patients with acute myeloid leukemia and 34-58% of hematopoietic stem cell transplant recipients. Platelet transfusion refractoriness, the repeated failure to obtain satisfactory response to platelet transfusions, is a common problem. Alternatives to platelet transfusions are desperately needed for these patients.

Epsilon aminocaproic acid (EACA) blocks a process called fibrinolysis that is an essential step in the bleeding process. EACA is approved by the FDA for the treatment of severe bleeding-related diseases and complications. A small study has shown EACA to be well tolerated and associated with low risk of bleeding in patients with hematological malignancies.

This study will compare EACA versus standard prophylactic platelet transfusion for the prevention of bleeding in thrombocytopenic patients with hematological malignancies.

STUDY DESCRIPTION:

This is Phase II study to compare EACA versus standard prophylactic platelet transfusion to prevent bleeding in thrombocytopenic patients with hematological malignancies. Patients who are eligible to take part must give their written agreement before they can be enrolled.

The study will enroll 100 patients who will be assigned randomly to take EACA twice daily or to undergo standard prophylactic platelet transfusion. Patients will be followed for any bleeding events, need for platelet transfusion, and any side effects experienced. Patients will complete questionnaires to assess their quality of life while on the study.


Condition or disease Intervention/treatment Phase
Hematological Malignancies Thrombocytopenia Drug: EACA Other: Platelet transfusion Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Epsilon Aminocaproic Acid Versus Platelet Transfusions for the Prevention of Bleeding in Thrombocytopenic Patients With Hematological Malignancies
Study Start Date : May 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prophylactic EACA
Prophylactic EACA 1000 mg PO twice daily if platelets < 20 x 10⁹/L
Drug: EACA
EACA 1000 mg twice a day. Patients will receive platelet transfusion in case of grade ≥ 2 bleeding.
Other Names:
  • Amicar
  • Aminocaproic acid

Active Comparator: Platelet transfusion
Platelet transfusion if platelet count is < 20 x 10⁹/L in the outpatient or < 10 x 10⁹/L in the inpatient setting
Other: Platelet transfusion
Prophylactic platelet transfusion. Additional platelet transfusions will be administered in case of grade ≥ 2 bleeding.




Primary Outcome Measures :
  1. Proportion of patients who develop major bleeding episodes (WHO grades 3-4) [ Time Frame: 6 months ]
    The primary objective of this study is to compare the proportion of patients who develop major bleeding episodes (WHO grades 3-4) in the group randomized to receive prophylactic EACA versus standard of care prophylactic platelet transfusions.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 with a hematological malignancy
  • Informed consent
  • Thrombocytopenia with untransfused platelet counts < 20 x 10⁹/L in the out-patient or in the in-patient setting and one of the following criteria:

    • Acute thrombocytopenia in patients with hematological malignancies who are in remission and are receiving myelosuppressive consolidation chemotherapy that is expected to induce marrow aplasia for at least 2 weeks; or
    • Acute or chronic thrombocytopenia in patients with acute leukemia (myeloblastic or lymphoblastic) receiving induction or re-induction chemotherapy that is expected to induce marrow aplasia for at least 2 weeks; or
    • Expected chronic thrombocytopenia in patients with newly diagnosed marrow failure syndromes, myelodysplastic syndromes, aplastic anemia, chronic myelomonocytic leukemia or myelofibrosis; or
    • Expected chronic thrombocytopenia in patients with relapsed or refractory hematological malignancies; or
    • Hematopoietic stem cell transplant recipients with chronic thrombocytopenia due to chronic graft-versus-host disease (GVHD) or other causes

Exclusion Criteria:

  • Acute promyelocytic leukemia
  • Patient receiving anticoagulation
  • Patient receiving antiplatelet agents
  • Patient treated with antifibrinolytic agents (including EACA) within 14 days prior to screening
  • Subjects receiving procoagulant agent including DDAVP, recombinant factor VII or prothrombin complex concentrate within 24 hours of enrollment
  • Subject with known congenital bleeding disorders or platelet dysfunction
  • Disseminated intravascular coagulation
  • Fibrinogen level < 150 mg/dl
  • Patients with known lupus anticoagulant or positive antiphospholipid antibody
  • History of arterial or venous thromboembolic disease 6 months prior to screening
  • Patient requiring platelet transfusion threshold of > 20 x 10⁹/L
  • Active grade ≥ 2 bleeding at the time of randomization, including hematuria
  • History of grade 4 bleeding
  • Hematopoietic stem cell transplant recipient within 100 days post-transplant
  • Pregnancy
  • Known allergy to EACA
  • History of veno-occlusive disease of the liver
  • Myocardial infarction 6 months prior to screening
  • Unstable angina
  • Grade 2 renal dysfunction: creatinine > 2-3 times the upper limit of normal

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): NCT02074436


Contacts
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Contact: Ana G. Antun, MD, MSc 404-593-6732 ana.antun@emoryhealthcare.org
Contact: Shannon Gleason 404-778-4334 shannon.gleason@emory.edu

Locations
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United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ana Antun, MD, MSc    404-593-6732    ana.antun@emoryhealthcare.org   
Principal Investigator: Ana G. Antun, MD, MSc         
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Ana Antun, MD, MSc    404-593-6732    ana.antun@emoryhealthcare.org   
Principal Investigator: Wayne B. Harris, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Ana G. Antun, MD, MSc Emory University

Publications:
2. Gernsheimer, TB Platelet transfusion in the 21st century, ISBT 2011;6: 245-248
3. Paolo Rebulla, M.D., Guido Finazzi, M.D., Francesca Marangoni, M.D., Giuseppe Avvisati, M.D., Luigi Gugliotta, M.D., Gianni Tognoni, M.D., Tiziano Barbui, M.D., Franco Mandelli, M.D., and Girolamo Sirchia, M.D. for the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto N Engl J Med 1997; 337:1870-187

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Responsible Party: Ana G. Antun, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02074436     History of Changes
Other Study ID Numbers: IRB00066504
Winship2429-13 ( Other Identifier: Winship Cancer Institute/Emory University )
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by Ana G. Antun, MD, Emory University:
hematological malignancies
thrombocytopenia
aminocaproic acid
Additional relevant MeSH terms:
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Thrombocytopenia
Neoplasms
Blood Platelet Disorders
Hematologic Diseases
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants