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American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT) - DCC

美国使用氨甲环酸治疗血小板减少症的试验 (A-TREAT) - DCC

基本信息

批准号：
9494418
负责人：
Susanne May
金额：
$ 52.23万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-15 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9494418
关键词：
6-Aminocaproic Acid Accounting Achievement Address Adherence Adopted Affect Amendment American Antifibrinolytic Agents Blinded Blood Blood Platelets Blood coagulation Bone Marrow Diseases Case Report Form Clinic Clinical Clinical Trials Clinical Trials Data Monitoring Committees Coagulation Process Collaborations Communities Critical Illness Data Data Coordinating Center Data Set Defect Development Dictionary Disease Dose Double-Blind Method Eligibility Determination Ensure Event Fibrinolysis Funding Funding Agency Future Goals Hematopoietic stem cells Hemophilia A Hemorrhage Hospitals Human Resources Immunotherapy Incidence Informatics Information Dissemination Inpatients Institutional Review Boards Interview Investigation Knowledge Laboratories Lead Letters Link Maintenance Manuals Manuscripts Marrow Meta-Analysis Methods Monitor National Health Services National Heart, Lung, and Blood Institute Online Systems Outpatients Patient Care Patients Pharmaceutical Preparations Phase Physical Examination Physicians Placebos Platelet Count measurement Platelet Transfusion Postoperative Period Preparation Prevention Procedures Protocols documentation Radiation Radiation therapy Randomized Refractory Reporting Research Research Design Research Personnel Safety Sample Size Sampling Secondary to Site Visit Source Statistical Data Interpretation Statistical Models Testing Therapeutic Trials Thrombocytopenia Thrombosis Time Training Tranexamic Acid Transfusion Transplantation United Kingdom Universities Washington Work Writing arm base chemotherapy clinical research site data management design diaries experience human subject improved inhibitor/antagonist operation patient population placebo controlled study prevent professor prophylactic prospective public health relevance randomized placebo controlled trial randomized trial recruit sound standard of care treatment effect

项目摘要

DESCRIPTION (provided by applicant): Despite major advances in platelet transfusion therapy, bleeding remains a problem in patients with thrombocytopenia due to chemotherapy induced marrow aplasia and hematopoietic stem cell disorders. Bleeding incidence does not appear to be affected by increasing the platelet transfusion threshold and does not appear to be dependent on the platelet count when it is above 5,000/µl. In the PLADO (Platelet Dose) Trial of 1272 patients, WHO grade 2 bleeding occurred in approximately 70% of subjects regardless of platelet dose transfused. Similarly in a 600 patient trial of therapeutic vs. prophylactic platelet transfusion (TOPPS), bleeding remained a common event. Withholding transfusion may lead to serious and fatal bleeding. Maintenance of a safe platelet count may be difficult due to shortening of platelet survival in severely thrombocytopenic and critically ill patients. Patients refractory to platelet transfusion may require expensive and difficult to obtain matched platelets. Maintenance of the platelet count above a prescribed trigger in outpatients may require daily laboratory work and frequent transfusions. Other means used to decrease bleeding include treatment with antifibrinolytic agents, used for years intra- and postoperatively and in patients with platelet function and coagulation defects such as hemophilia. Reports of antifibrinolytic drugs to prevent or treat thrombocytopenic bleeding are encouraging and suggest that in many patients bleeding can be prevented or stopped. Such anecdotal, retrospective single center reports lead many physicians to prescribe antifibrinolytic agents in thrombocytopenic patients refractory to platelet transfusions. However lack of evidence of efficacy and safety prevent this becoming standard of care. A pivotal study of Epsilon Aminocaproic Acid (EACA), an inhibitor of fibrinolysis, will improve patient care by leading physicians to either adopt it or abandon its use as treatment for prevention of thrombocytopenic bleeding. We plan to conduct a prospective, randomized, placebo controlled trial evaluating the usefulness of EACA therapy to prevent bleeding in patients thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. This study will change practice by providing evidence as to whether EACA is effective and safe when used as an adjunct to platelet transfusion therapy. The objectives are too compare the 30 day incidences of bleeding, transfusion, and thrombosis in patients with hypoproliferative thrombocytopenia secondary to primary marrow disorder, HSCT, or chemotherapy, immunotherapy and/or radiation randomized to receive EACA or placebo. The study design is a double blind, randomized, placebo controlled trial. Subjects likely to have platelet counts of =10,000/µl for =5 days will be screened for eligibility Bleeding and thrombotic assessments will be performed on inpatients daily using chart review, subject interview and physical examination. Outpatient subjects will maintain a diary daily and be seen at least weekly in clinic.