NCT03653429

Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Completed Phase 4 Results posted Last updated 29 April 2020

What this trial tests

Phase 4 trial testing Tranexamic Acid in Foot and Ankle Surgeries in 100 participants. Completed in 31 December 2018.

Timeline

1 March 2018

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 March 2018
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	2 locations across United States

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →
• Normal saline

Conditions studied

• Foot and Ankle Surgeries — all drugs for Foot and Ankle Surgeries →
• Bunion — all drugs for Bunion →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 75, any sex, with Foot and Ankle Surgeries or Bunion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Estimated Blood Loss Primary · Average intra operative time 1-2 hours

Total estimated blood loss in millilitres during the surgery

Group	Value	95% CI
Tranexamic Acid Group	40.41	± 136.78
Normal Saline Group	18.75	± 49.40

Number of Participants With Wound Complications Secondary · at first post-operative visit, 2 weeks post surgery

Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery

first post-operative visit

Group	Value	95% CI
Tranexamic Acid Group	8
Normal Saline Group	8

2 weeks post surgery

Group	Value	95% CI
Tranexamic Acid Group	8
Normal Saline Group	8

Intra Operative Narcotic Consumption Secondary · Average intra operative time 1-2 hours

Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)

Group	Value	95% CI
Tranexamic Acid Group	93.37	± 58.80
Normal Saline Group	125.40	± 79.17

Post Operative Narcotic Consumption Secondary · 2 weeks after surgery

Post operative narcotic consumption, morphine mili equivalents

Group	Value	95% CI
Tranexamic Acid Group	6.12	± 13.32
Normal Saline Group	10.10	± 22.21

Sponsor's own description

Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

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