Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hip Fractures
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation. Treatment drug and saline placebo will be blinded from the patient. Tre...

Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation. Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.

Tracking Information

NCT #
NCT04488367
Collaborators
Not Provided
Investigators
Principal Investigator: Michael Allen, DO Resident physician