Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-07-01

Brief Summary

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To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.

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Detailed Description

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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.

Conditions

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Hemorrhage Postoperative Anterior Cruciate Ligament Rupture Arthroscopy Total Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded prospective randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patient, anesthesiologist and surgeon are blinded

Study Groups

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Oral Tranexamic Acid

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Group Type ACTIVE_COMPARATOR

Oral tablet

Intervention Type DRUG

Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration

Placebo

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of lactose tablet (placebo)

Interventions

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Oral tablet

Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration

Intervention Type DRUG

Placebo

Oral administration of lactose tablet (placebo)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary arthroscopic surgery for anterior cruciate ligament reconstruction

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No