drugset / Trial / NCT03954860
Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
RandomizedParallel-groupSingle-blindTreatment
Summary
The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.
Timeline
- Start
- 2018-08-01
- Primary completion
- 2019-09-01
- Completion
- 2019-09-01
Publications
- Background Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20.
- Background Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
- Background Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29.
- Background Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8.
- Background Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525.
- Background Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728.
- Background Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273.
- Background Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013.
- Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 20 mg/kg | Intravenous |
| Subject | Tranexamic Acid | Small molecule | 2 g | Intravenous |
| Background | sodium chloride | Unknown | 30 ml | Intravenous |
| Background | sodium chloride | Unknown | 100 ml | Intravenous |