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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855877
• Other study ID #: TRANEX-LCA
• Status: Recruiting
• Phase: Phase 4
• Start date: July 6, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2021
• Source: University of Liege
• Contact: Nicolas Piette, MD
• Phone: 003242843824
• Email: piettenicolas[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Arthroscopy
• Hemarthrosis
• Hemorrhage
• Hemorrhage Postoperative
• Postoperative Hemorrhage
• Rupture
• Total Blood Loss

Intervention

Drug:
• 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
• Placebo
Oral administration of lactose tablet (placebo)

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of haemarthrosis	Postoperative (drainage) blood loss	First 24 hours after surgery
Secondary	Postoperative pain	Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)	24 hours after surgery
Secondary	Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	72 hours after surgery
Secondary	Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	7 days after surgery
Secondary	Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	15 days after surgery
Secondary	Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	1 days after surgery
Secondary	Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	3 days after surgery
Secondary	Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	7 days after surgery
Secondary	Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	15 days after surgery
Secondary	Length of hospital stay	Total days of hospitalization	First 30 days after surgery