Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

2021-153

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

2023-04-12

2028-06-30

2030-06-30

Recruiting

Early phase I

130

Inclusion Criteria: 1. Males or females age 18-100 years 2. Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation. 3. Must be able to read and understand English and consent for themselves. Exclusion Criteria: 1. Allergy to TXA. 2. Acquired disturbances of color vision. 3. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA. 4. Pregnant or breastfeeding. 5. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement. 6. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men) 7. Refusal of blood products 8. Subarachnoid hemorrhage 9. Disseminated intravascular coagulation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

2023-04-20