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

• Sponsor: University of Liege (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04855877
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage Postoperative; Anterior Cruciate Ligament Rupture; Arthroscopy; Total Blood Loss	Drug: Oral tablet; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blinded prospective randomized controlled trialDouble blinded prospective randomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Patient, anesthesiologist and surgeon are blinded
• Primary Purpose: Supportive Care
• Official Title: Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?
• Actual Study Start Date: Jul 6, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Tranexamic Acid 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy	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 Comparator: Placebo 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy	Drug: Placebo; Oral administration of lactose tablet (placebo)

Outcome Measures

Primary Outcome Measures

1. Assessment of haemarthrosis [First 24 hours after surgery]

   Postoperative (drainage) blood loss

Secondary Outcome Measures

1. Postoperative pain [24 hours after surgery]

   Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)

2. Postoperative pain [72 hours after surgery]

   Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

3. Postoperative pain [7 days after surgery]

   Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

4. Postoperative pain [15 days after surgery]

   Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)

5. Clinical evaluation of functional recovery [1 days after surgery]

   Tegner activity score from 0 (no activity) to 10 (competitive sport)

6. Clinical evaluation of functional recovery [3 days after surgery]

   Tegner activity score from 0 (no activity) to 10 (competitive sport)

7. Clinical evaluation of functional recovery [7 days after surgery]

   Tegner activity score from 0 (no activity) to 10 (competitive sport)

8. Clinical evaluation of functional recovery [15 days after surgery]

   Tegner activity score from 0 (no activity) to 10 (competitive sport)

9. Length of hospital stay [First 30 days after surgery]

   Total days of hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Liège	Liège		Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Karaaslan F, Karaoğlu 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.
• 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.

• Responsible Party: Jean François Brichant, Head of Anesthesiology Departement, University of Liege
• ClinicalTrials.gov Identifier: NCT04855877
• Other Study ID Numbers: TRANEX-LCA
• First Posted: Apr 22, 2021
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemarthrosis; Hemorrhage; Exsanguination; Postoperative Hemorrhage; Rupture

Study Results

No Results Posted as of Jul 28, 2021