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

Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?

Sponsors

Lead Sponsor: University of Liege

Source University of Liege
Brief Summary

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.

Detailed 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.

Overall Status Not yet recruiting
Start Date 2021-06-01
Completion Date 2023-07-01
Primary Completion Date 2023-06-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessment of haemarthrosis First 24 hours after surgery
Secondary Outcome
Measure Time Frame
Postoperative pain 24 hours after surgery
Postoperative pain 72 hours after surgery
Postoperative pain 7 days after surgery
Postoperative pain 15 days after surgery
Clinical evaluation of functional recovery 1 days after surgery
Clinical evaluation of functional recovery 3 days after surgery
Clinical evaluation of functional recovery 7 days after surgery
Clinical evaluation of functional recovery 15 days after surgery
Length of hospital stay First 30 days after surgery
Enrollment 104
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oral tablet

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

Arm Group Label: Oral Tranexamic Acid

Intervention Type: Drug

Intervention Name: Placebo

Description: Oral administration of lactose tablet (placebo)

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Nicolas Piette, MD

Phone: 003242843824

Email: [email protected]

Location
Facility: CHU de Liège
Location Countries

Belgium

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Liege

Investigator Full Name: Jean François Brichant

Investigator Title: Head of Anesthesiology Departement

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Oral Tranexamic Acid

Type: Active Comparator

Description: 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Label: Placebo

Type: Placebo Comparator

Description: 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Double blinded prospective randomized controlled trial

Primary Purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Patient, anesthesiologist and surgeon are blinded

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