NCT03211286

Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients

Completed Phase 4 Last updated 7 April 2022

What this trial tests

Phase 4 trial testing Tranexamic Acid in Hip Fractures in 129 participants. Completed in 8 March 2022.

Timeline

30 January 2018

Primary endpoint
2 March 2021

8 March 2022

Quick facts

Lead sponsor	Alejandro Lizaur-Utrilla, PhD, MD
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	129
Start date	30 January 2018
Primary completion	2 March 2021
Estimated completion	8 March 2022
Sites	2 locations across Spain

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →
• Saline Solution

Conditions studied

• Hip Fractures — all drugs for Hip Fractures →
• Anemia — all drugs for Anemia →

Sponsor

Alejandro Lizaur-Utrilla, PhD, MD

Who can join

60 and older, any sex, with Hip Fractures or Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.

Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited.

Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.

The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.

Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.

This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic and long bone fractures.
   Gibbs VN, Geneen LJ, Champaneria R, Raval P, et al · · 2023 · cited 16× · PMID 37272509 · DOI 10.1002/14651858.cd013499.pub2