drugset / Trial / NCT04178655
Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the effect of pre-operative treatment with IV Tranexamic Acid on post-operative digit function, in patients that underwent surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tear.
Timeline
- Start
- 2019-11
- Primary completion
- 2022-11
- Completion
- 2023-03
Publications
- Background Pulos N, Bozentka DJ. Management of complications of flexor tendon injuries. Hand Clin. 2015 May;31(2):293-9. doi: 10.1016/j.hcl.2014.12.004. Epub 2015 Feb 28.
- Background Legrand A, Kaufman Y, Long C, Fox PM. Molecular Biology of Flexor Tendon Healing in Relation to Reduction of Tendon Adhesions. J Hand Surg Am. 2017 Sep;42(9):722-726. doi: 10.1016/j.jhsa.2017.06.013. Epub 2017 Jul 12.
- Background Khanna A, Friel M, Gougoulias N, Longo UG, Maffulli N. Prevention of adhesions in surgery of the flexor tendons of the hand: what is the evidence? Br Med Bull. 2009;90:85-109. doi: 10.1093/bmb/ldp013. Epub 2009 Apr 24.
- Background Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005 Jan;87(1):187-202. doi: 10.2106/JBJS.D.01850.
- Background Ishiyama N, Moro T, Ohe T, Miura T, Ishihara K, Konno T, Ohyama T, Kimura M, Kyomoto M, Saito T, Nakamura K, Kawaguchi H. Reduction of Peritendinous adhesions by hydrogel containing biocompatible phospholipid polymer MPC for tendon repair. J Bone Joint Surg Am. 2011 Jan 19;93(2):142-9. doi: 10.2106/JBJS.I.01634.
- Background Murphy PG, Loitz BJ, Frank CB, Hart DA. Influence of exogenous growth factors on the synthesis and secretion of collagen types I and III by explants of normal and healing rabbit ligaments. Biochem Cell Biol. 1994 Sep-Oct;72(9-10):403-9. doi: 10.1139/o94-054.
- Background Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.
- Background Aguilera X, Martinez-Zapata MJ, Hinarejos P, Jordan M, Leal J, Gonzalez JC, Monllau JC, Celaya F, Rodriguez-Arias A, Fernandez JA, Pelfort X, Puig-Verdie Ll. Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial. Arch Orthop Trauma Surg. 2015 Jul;135(7):1017-25. doi: 10.1007/s00402-015-2232-8. Epub 2015 May 7.
- Background CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.
- Background McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray. Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
- Background Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.
- Background Oremus K, Sostaric S, Trkulja V, Haspl M. Influence of tranexamic acid on postoperative autologous blood retransfusion in primary total hip and knee arthroplasty: a randomized controlled trial. Transfusion. 2014 Jan;54(1):31-41. doi: 10.1111/trf.12224. Epub 2013 Apr 25.
- Background Frueh FS, Kunz VS, Gravestock IJ, Held L, Haefeli M, Giovanoli P, Calcagni M. Primary flexor tendon repair in zones 1 and 2: early passive mobilization versus controlled active motion. J Hand Surg Am. 2014 Jul;39(7):1344-50. doi: 10.1016/j.jhsa.2014.03.025. Epub 2014 May 5.
- Background Jansen CW, Watson MG. Measurement of range of motion of the finger after flexor tendon repair in zone II of the hand. J Hand Surg Am. 1993 May;18(3):411-7. doi: 10.1016/0363-5023(93)90083-f.
- Background Strickland JW, Glogovac SV. Digital function following flexor tendon repair in Zone II: A comparison of immobilization and controlled passive motion techniques. J Hand Surg Am. 1980 Nov;5(6):537-43. doi: 10.1016/s0363-5023(80)80101-8.
- Background Tang JB. Outcomes and evaluation of flexor tendon repair. Hand Clin. 2013 May;29(2):251-9. doi: 10.1016/j.hcl.2013.02.007.
- Background Elliot D, Harris SB. The assessment of flexor tendon function after primary tendon repair. Hand Clin. 2003 Aug;19(3):495-503. doi: 10.1016/s0749-0712(03)00028-3.
- Background MacDermid JC. Measurement of health outcomes following tendon and nerve repair. J Hand Ther. 2005 Apr-Jun;18(2):297-312. doi: 10.1197/j.jht.2005.02.009.
- Background Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Background Hoang-Kim A, Pegreffi F, Moroni A, Ladd A. Measuring wrist and hand function: common scales and checklists. Injury. 2011 Mar;42(3):253-8. doi: 10.1016/j.injury.2010.11.050. Epub 2010 Dec 15.
- Background Libberecht K, Lafaire C, Van Hee R. Evaluation and functional assessment of flexor tendon repair in the hand. Acta Chir Belg. 2006 Sep-Oct;106(5):560-5. doi: 10.1080/00015458.2006.11679952.
- Background Dacombe PJ, Amirfeyz R, Davis T. Patient-Reported Outcome Measures for Hand and Wrist Trauma: Is There Sufficient Evidence of Reliability, Validity, and Responsiveness? Hand (N Y). 2016 Mar;11(1):11-21. doi: 10.1177/1558944715614855. Epub 2016 Jan 13.
- Background MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.