Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement
NCT ID: NCT01850394
Last Updated: 2013-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2010-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control group
physiologic saline 25 ml
Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Interventions
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Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
* no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Viroj Kawinwonggowit
Clinical Professor
Locations
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Ramathibodi Hospital
Bangkok, , Thailand
Countries
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References
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Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29.
Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.
Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.
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.
Seo JG, Moon YW, Park SH, Kim SM, Ko KR. The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1869-74. doi: 10.1007/s00167-012-2079-2. Epub 2012 Jun 24.
Sa-Ngasoongsong P, Wongsak S, Chanplakorn P, Woratanarat P, Wechmongkolgorn S, Wibulpolprasert B, Mulpruek P, Kawinwonggowit V. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Dec 5;14:340. doi: 10.1186/1471-2474-14-340.
Other Identifiers
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ID 01-53-06
Identifier Type: -
Identifier Source: org_study_id