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To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
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 | 128 patients scheduled for primary total hip arthroplasty |
|
| Intravenous Tranexamic Acid | Active Comparator | 128 patients scheduled for primary total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Oral Product | 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 |
|---|---|---|
| Total blood loss | Peroperative (suction) and postoperative (drainage) total blood loss | First 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 2 hours after oral administration |
| Serum concentration of tranexamic acid |
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Inclusion Criteria:
- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | 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. | |
| 30312799 |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D058734 | Exsanguination |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
| Tranexamic acid injection | Drug | Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration |
|
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
| 6 hours after oral administration |
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 30 minutes after intravenous administration |
| Serum concentration of tranexamic acid | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group | 4 hours after intravenous administration |
| Serum hemoglobin variation | Variation of serum hemoglobin between preoperative and postoperative period | 24 hours after surgery |
| Serum hemoglobin variation | Variation of serum hemoglobin between preoperative and postoperative period | 72 hours after surgery |
| Incidence of blood transfusion | Incidence of blood transfusion in two groups | 72 hours after surgery |
| Incidence of thromboembolic complications | Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis | 72 hours after surgery |
| Length of hospitalisation stay | Difference between two groups of total hospitalisation days | 1 week after surgery |
| Background |
| Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6. |
| 38214552 | Derived | Piette N, Beck F, Carella M, Hans G, Maesen D, Kurth W, Lecoq JP, Bonhomme VL. Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):217-225. doi: 10.1097/EJA.0000000000001950. Epub 2024 Jan 12. |