Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Hip Fractures, Blood Loss
In brief
The primary objective of this study is to assess the safety and efficacy of Tranexamic acid (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip fractures. In addition to assessing blood loss in these patients, complications associated with TXA use would be characterized including systemic (pulmonary embolism, deep venous thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events, need for re-hospitalization or re-operation and 30 day mortality.
Key facts
- Study ID
- NCT02908516
- Run by
- Yale University
- People needed
- 6
- Starts
- 2017-09-18
- Expected to finish
- 2017-12-15
- Last updated by the study team
- 2019-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur fractures Patients age 18 and older Low energy injury
You may not qualify if…
- Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia Myeloproliferative disorders International Normalized Ratio (INR) > 1.4 Partial Thromboplastin Time (PTT) > 1.4 times normal A history of arterial or venous thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical trial
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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