Clinical trial NCT04855877: Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis
Official title: Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemorrhage Postoperative
Anterior Cruciate Ligament Rupture
Arthroscopy
Total Blood Loss
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded prospective randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Assessment of haemarthrosis
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery
measure: Postoperative pain
timeFrame: 72 hours after surgery
measure: Postoperative pain
timeFrame: 7 days after surgery
measure: Postoperative pain
timeFrame: 15 days after surgery
measure: Clinical evaluation of functional recovery
timeFrame: 1 days after surgery
measure: Clinical evaluation of functional recovery
timeFrame: 3 days after surgery
measure: Clinical evaluation of functional recovery
timeFrame: 7 days after surgery
measure: Clinical evaluation of functional recovery
timeFrame: 15 days after surgery
measure: Length of hospital stay
timeFrame: First 30 days after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References:
citation: Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
citation: Muhunthan K, Balakumar S, Navaratnaraja TS, Premakrishna S, Arulkumaran S. Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. Obstet Gynecol. 2020 Apr;135(4):945-948. doi: 10.1097/AOG.0000000000003750.
citation: Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.