Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures

Description

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.

Study Start Date

September 18, 2017

Estimated Completion Date

February 2018

Interventions

  • Drug: Tranexamic Acid
  • Drug: Placebo

Study ID

Yale University -- 100 FR 1 (2015-2)

Status

Unknown

Trial ID

NCT02908516

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

100

Sponsor

Yale University

Inclusion Criteria

    Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur fractures Patients age 18 and older Low energy injury

Exclusion Criteria

    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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Yale New Haven Hospital - New Haven, Connecticut 16.8 miles Stephen K Nelson MD 860-463-5933 stephen.nelson@yale.edu

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