Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-07-15
2023-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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intravenous tranexamic acid
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.
Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
placebo
The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride).
Normal saline
0.9% sodium chloride normal saline
Interventions
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Tranexamic Acid 100 MG/ML
Tranexamic Acid: 100 MG/ML Solution for injection
Normal saline
0.9% sodium chloride normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Secondary arthritis (ex., Rheumatic arthritis, traumatic arthritis, septic arthritis)
* BMI less than 20 and more than 40.
* Patients having vascular or hematologic disease.
* Patients who were taking anti-coagulant medicine and couldn't stop it.
* Patients having acute or chronic renal failure.
* Patients classified as the AAA as grade four or five.
* Patients with intra-operative complications such as intra-operative fractures or vascular injuries.
* Post-traumatic and secondary knee arthritis patients.
* Revisions and complex primary cases.
* Patients with an active infection or a history of lower limp infection.
40 Years
70 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Jaber Ibrahim, M.D, Ph.D
Role: STUDY_DIRECTOR
Damascus University
Locations
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Damascus university
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Berman AT, Geissele AE, Bosacco SJ. Blood loss with total knee arthroplasty. Clin Orthop Relat Res. 1988 Sep;(234):137-8.
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.
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.
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.
Other Identifiers
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UDMS-Orthopedics-4-2023
Identifier Type: -
Identifier Source: org_study_id
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