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NCT02074436 · ClinicalTrials.gov registry record · Phase 2
PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid)
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT02074436 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 29 participants.
The verdict
NCT02074436, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- DRUG EACA
- OTHER Platelet transfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2021-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02074436
The ClinicalTrials.gov registry entry for NCT02074436 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EACA is the first listed.
NCT02074436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02074436 about?
NCT02074436 is a clinical study titled "PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid)". 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...
What is the current status of trial NCT02074436?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2014-05-23. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT02074436?
The interventions under investigation include: EACA (DRUG), Platelet transfusion (OTHER).
Who is sponsoring clinical trial NCT02074436?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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