NCT03897621

The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

Completed NA Last updated 14 April 2023

What this trial tests

NA trial testing Tranexamic Acid in Coagulation; Intravascular in 50 participants. Completed in 20 December 2022.

Timeline

20 May 2019

Primary endpoint
20 December 2022

20 December 2022

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	20 May 2019
Primary completion	20 December 2022
Estimated completion	20 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →
• Placebo

Conditions studied

• Coagulation; Intravascular — all drugs for Coagulation; Intravascular →
• Rotational Thromboelastometry — all drugs for Rotational Thromboelastometry →
• Fibrinolysis; Hemorrhage — all drugs for Fibrinolysis; Hemorrhage →
• Tranexamic Acid — all drugs for Tranexamic Acid →

Sponsor

Thomas Jefferson University

Who can join

Adults 18 to 85, any sex, with Coagulation; Intravascular or Rotational Thromboelastometry. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological interventions for the prevention of bleeding in people undergoing elective hip or knee surgery: a systematic review and network meta-analysis.
   Gibbs VN, Champaneria R, Sandercock J, Welton NJ, et al · · 2024 · cited 19× · PMID 38226724 · DOI 10.1002/14651858.cd013295.pub2
2. 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
3. The effect of tranexamic acid on blood coagulation in primary total hip arthroplasty using rotational thromboelastometry: a randomized controlled trial.
   Yoon U, Beausang D, Elia E, Torjman M, et al · · 2025 · cited 1× · PMID 40735345 · DOI 10.1016/j.eclinm.2025.103374