NCT04089865

Oral Versus Intravenous Tranexamic Acid

Completed Phase 4 Results posted Last updated 27 December 2024

What this trial tests

Phase 4 trial testing Tranexamic Acid in Blood Loss in 400 participants. Completed in 10 November 2021.

Timeline

17 September 2019

Primary endpoint
10 November 2021

10 November 2021

Quick facts

Lead sponsor	Hospital for Special Surgery, New York
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	17 September 2019
Primary completion	10 November 2021
Estimated completion	10 November 2021
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Blood Loss — all drugs for Blood Loss →
• Blood Transfusion — all drugs for Blood Transfusion →

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 18 to 80, any sex, with Blood Loss or Blood Transfusion. 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.

Calculated Blood Loss Primary · post-operative day 0

Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across

Group	Value	95% CI
Oral Tranexamic Acid (TXA) Total Hip Arthroplasty	842	± 328
Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty	860	± 313
Oral Tranexamic Acid (TXA) Total Knee Arthroplasty	799	± 334
Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty	878	± 348

Transfusion During Hospital Stay Secondary · From Post-Operative Day 0 to Post-Operative Day 2

To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).

Group	Value	95% CI
Oral Tranexamic Acid (TXA) Total Hip Arthroplasty	0
Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty	0
Oral Tranexamic Acid (TXA) Total Knee Arthroplasty	0
Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty	1

Time to Discharge From Physical Therapy Secondary · From 48-72 hours after surgery

Time to discharge from physical therapy (in minutes)

Group	Value	95% CI
Oral Tranexamic Acid (TXA) Total Hip Arthroplasty	2091.33	± 1203.17
Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty	1914.45	± 1055.47
Oral Tranexamic Acid (TXA) Total Knee Arthroplasty	2244.55	± 1327.44
Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty	2285.09	± 1499.37

Length of Stay Secondary · After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)

Hospital length of stay (in minutes)

Group	Value	95% CI
Oral Tranexamic Acid (TXA) Total Hip Arthroplasty	2551.89	± 1554.4
Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty	2138.6	± 1126.71
Oral Tranexamic Acid (TXA) Total Knee Arthroplasty	2692.98	± 1508.65
Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty	2852.55	± 1511.05

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment through study completion, an average of 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Tranexamic Acid (TXA) Total Hip Arthroplasty

Serious: 0/89 (0%)

Deaths: 0/89

Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty

Serious: 1/90 (1%)

Deaths: 0/90

Oral Tranexamic Acid (TXA) Total Knee Arthroplasty

Serious: 0/90 (0%)

Deaths: 0/90

Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty

Serious: 0/96 (0%)

Deaths: 0/96

Serious adverse events (1 terms)

Reaction	System	Oral Tranexamic Acid (TXA)…	Intravenous (IV) Tranexami…	Oral Tranexamic Acid (TXA)…	Intravenous (IV) Tranexami…
CVA, cerebrovascular accident	Vascular disorders	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Oral Tranexamic Acid (TXA)…	Intravenous (IV) Tranexami…	Oral Tranexamic Acid (TXA)…	Intravenous (IV) Tranexami…
Complications	Blood and lymphatic system disorders	—	—	—	—

Most-reported serious reactions: CVA, cerebrovascular accident.

Data from ClinicalTrials.gov NCT04089865 adverse events section.

Sponsor's own description

The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).

Publications & conference data

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

1. Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.
   DeFrancesco CJ, Reichel JF, Gbaje E, Popovic M, et al · · 2023 · cited 28× · PMID 36526484 · DOI 10.1016/j.bja.2022.11.003
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