Effect of Early Administration of TXA in Adult Hip Fractures

Part of paid clinical trials in Grand Blanc, Michigan.

Sponsor
Ascension Health
Study ID
NCT05047133
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Postoperative Blood Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tranexamic acid — DRUG
    TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups

Study Details

This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

Key Dates

Start date
Sep 1, 2021
Status verified
Sep 2021
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Early Adminstration of TXA + Intraoperative TXA
    This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.
  • Other: Intraoperative only TXA
    This group will only receive the intraoperative TXA.

Primary Outcome Measure

Postoperative Blood Transfusion [ Time Frame: Up to two weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascension Genesys HospitalGrand BlancMichigan48439
Sandra Watt, MS, BSN
810-606-7713

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