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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Tranexamic Acid | Active Comparator | 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy |
|
| Placebo | Placebo Comparator | 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral tablet | Drug | Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of haemarthrosis | Postoperative (drainage) blood loss | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain) | 24 hours after surgery |
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Piette, MD | Contact | 003242843824 | piettenicolas@me.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Recruiting | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30640647 | Background | 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. | |
| 32168220 |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D000070598 | Anterior Cruciate Ligament Injuries |
| D058734 | Exsanguination |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Double blinded prospective randomized controlled trial
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Patient, anesthesiologist and surgeon are blinded
| Placebo | Drug | Oral administration of lactose tablet (placebo) |
|
| 72 hours after surgery |
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) | 7 days after surgery |
| Postoperative pain | Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) | 15 days after surgery |
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 1 days after surgery |
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 3 days after surgery |
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 7 days after surgery |
| Clinical evaluation of functional recovery | Tegner activity score from 0 (no activity) to 10 (competitive sport) | 15 days after surgery |
| Length of hospital stay | Total days of hospitalization | First 30 days after surgery |
| Background |
| 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. |
| 26337246 | Background | 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. |
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |