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

NCT02908516 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-07-29

Study results available
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Summary

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.

Conditions

  • Hip Fractures
  • Blood Loss

Interventions

DRUG

Tranexamic Acid

2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.

DRUG

Placebo

2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Michael P Leslie, DO · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2017-11-14
Completion
2017-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908516 on ClinicalTrials.gov