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Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate without significant complications. In addition, many meta-analyses have confirmed these results. This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.
Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO) bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. The study is a prospective, randomized, triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months.
The study was done in Damascus, Syria. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. Participants who went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium chloride), formed the control group. In contrast, the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous tranexamic acid | Experimental | The intervention group comprised patients who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage. |
|
| placebo | Placebo Comparator | The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 100 MG/ML | Drug | Tranexamic Acid: 100 MG/ML Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss（TBL） | Total Blood Loss（TBL） in the perioperative period was calculated using the Gross formula, which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value | calculated by an equation at the 72h postoperative |
| intra-operative blood loss | the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage | measured during surgery time (From the time of the surgical incision at the beginning of the operation until the time of wound closure at the end of the operation), Which equals about an hour |
| post-operative blood loss | the amount of lost blood postoperatively will be calculated as the output of the drain bottle | measured once 2 days after surgery |
| hidden blood loss | the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss | measured once 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion rates | Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, throughout the patient's hospital stay. | from the day of surgery to the day of discharge,an expected average of 3 days |
| perioperative complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaber Ibrahim, M.D, Ph.D | Damascus University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damascus university | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22161917 | Background | Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. | |
| 25450009 | Background | Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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triple Blinded
| Normal saline | Drug | 0.9% sodium chloride normal saline |
|
|
such as infection, VTE, etc |
| assesed if happened within month interval untill 6 months after surgery |
| 28002321 | Background | Lin C, Qi Y, Jie L, Li HB, Zhao XC, Qin L, Jiang XQ, Zhang ZH, Ma L. Is combined topical with intravenous tranexamic acid superior than topical, intravenous tranexamic acid alone and control groups for blood loss controlling after total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2016 Dec;95(51):e5344. doi: 10.1097/MD.0000000000005344. |
| 28176599 | Background | Cankaya D, Dasar U, Satilmis AB, Basaran SH, Akkaya M, Bozkurt M. The combined use of oral and topical tranexamic acid is a safe, efficient and low-cost method in reducing blood loss and transfusion rates in total knee arthroplasty. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684725. doi: 10.1177/2309499016684725. |
| 9058494 | Background | Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res. 1997 Feb 1;85(3):195-206. doi: 10.1016/s0049-3848(97)00004-2. |
| 21512813 | Background | Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22. |
| 27194493 | Background | Nielsen CS, Jans O, Orsnes T, Foss NB, Troelsen A, Husted H. Combined Intra-Articular and Intravenous Tranexamic Acid Reduces Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. J Bone Joint Surg Am. 2016 May 18;98(10):835-41. doi: 10.2106/JBJS.15.00810. |
| 3409568 | Background | Berman AT, Geissele AE, Bosacco SJ. Blood loss with total knee arthroplasty. Clin Orthop Relat Res. 1988 Sep;(234):137-8. |
| 6829965 | Background | Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available. |
| 28217656 | Background | Marra F, Rosso F, Bruzzone M, Bonasia DE, Dettoni F, Rossi R. Use of tranexamic acid in total knee arthroplasty. Joints. 2017 Feb 7;4(4):202-213. doi: 10.11138/jts/2016.4.4.202. eCollection 2016 Oct-Dec. |
| 22419263 | Background | Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15. |
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |