Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

University of Liege

Status and phase: Completed; Phase 4

Conditions: Total Blood Loss; Hemorrhage Postoperative; Arthroplasty Complications

Treatments: Drug: Tranexamic Acid Oral Product; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04691362

2020-316

Details and patient eligibility

About

To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Full description

Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Enrollment: 230 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

Exclusion criteria

• Renal failure with serum creatinine level higher than 1,40 mg/dL
• Thromboembolic events in last 12 months before surgery
• Pregnancy
• Congenital or acquired coagulation diseases
• History of gastric surgery that could lead to malabsorption
• Diabetic gastro-paresis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups

Oral Tranexamic Acid

Active Comparator group

Description:

128 patients scheduled for primary total hip arthroplasty

Treatment:

Drug: Tranexamic Acid Oral Product

Intravenous Tranexamic Acid

Active Comparator group

Description:

128 patients scheduled for primary total hip arthroplasty

Treatment:

Drug: Tranexamic acid injection