NCT05518279

Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial

Withdrawn Phase 3 Last updated 24 August 2022

What this trial tests

Phase 3 trial testing Tranexamic Acid Pill in Hip Fractures. Withdrawn.

Timeline

1 September 2019

Primary endpoint
1 August 2021

1 September 2021

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	1 September 2019
Primary completion	1 August 2021
Estimated completion	1 September 2021

Drugs / interventions tested

• Tranexamic Acid Pill — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Hip Fractures — all drugs for Hip Fractures →
• Blood Loss — all drugs for Blood Loss →

Sponsor

Henry Ford Health System — full company profile →

Who can join

50 and older, any sex, with Hip Fractures or Blood Loss. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Blood transfusion rate
  Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department through the time of discharge from the hospital, assessed up to 7 days.
  Preoperative, intraoperative, and postoperative blood transfusions will be considered as the primary outcome measure. This outcome will be measured in number of units of packed red blood cells administered during the participant's hospital stay.
• Hemoglobin Level
  Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department to the time of discharge from the hospital, up to 7 days.
  Labs, specifically a complete blood count (CBC) to evaluate a hemoglobin level (in grams per deciliter), will be drawn at the following time points: Admission to the Emergency Department, nightly (9pm) for each day of hospitalization and one hour after completion of a blood transfusion.

Sponsor's own description

The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.