Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries

NCT04178655 | Unknown Early Phase 1

• 1 other identifier: 0219-19-RMC
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tendon Injury - Hand

Keywords

Tendon Injury, Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Anatomic Result at 4-Months post-operatively

  Measurement of the anatomical outcome for both Zone1 and Zone 2 tears will be achieved by measuring the Total Active Motion (TAM) using the American Society for Surgery of the Hand Criteria (ASSH). Active flexion of the MCPJ, PIP and DIP joints are measured in degrees, and summed. Extension deficits in these joints are measured in degrees, summed, and deducted from the flexion measurements. The full TAM of a finger is 260 degrees: MCPJ 85 degrees, PIPJ 110 degrees and DIPJ 65 degrees The TAM of the affected side can be compared to the normal contralateral side, and expressed as percentage of return of motion. The Change of the TAM from baseline will be recorded for at the planned serial follow-ups, as described below.

  Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up.

Secondary Outcomes (5)

• Anatomic Result at 2-weeks and 8-weeks post-operatively

  Serial documentation will take place pre-operatively, and post-operatively during out-patient clinic follow-ups on a planned basis at 2-weeks and 8-weeks post-operatively.

• Extent of finger and hand swelling

  Serial documentation will take place pre-operatively, and post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.

• Strength Result

  Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.

• Functional Result - DASH Score

  Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.

• Functional Result - PRWE Score

  Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.

Study Arms (2)

Tranexamic Acid Treatment

EXPERIMENTAL

1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Drug: Tranexamic acid injection

Placebo

PLACEBO COMPARATOR

10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Drug: PLACEBO

Interventions

Tranexamic acid injection DRUG

1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Tranexamic Acid Treatment

PLACEBO DRUG

10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears

You may not qualify if:

• Age \< 18
• Pregnant Women
• Patients that presented 3 weeks or later after the injury
• Medical history positive for Rheumatic disease
• Current active treatment with anti-coagulation medications
• Injury to more than one finger
• Presence of a fracture in the affected finger
• Presence of a nerve injury in the affected finger that won't enable early use and activation in early rehabilitation protocol
• Mangled extremity injury, degloving injury or other soft tissue injuries that won't enable primary closure of skin
• Previous tear of the affected tendon
• Degenerative tear of flexor tendon
• Tendon tear secondary to infection
• Previous injuries to contralateral side causing dysfunction and/or decreased fingers' range of motion
• Contraindications to Tranexamic acid treatment:
• Known hypersensitivity to tranexamic acid or to any other ingredient of the preparation.

Sponsors & Collaborators

• Rabin Medical Center: lead

Related Publications (24)

• 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.

  PMID: 25934203 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.

  PMID: 28709791 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.

  PMID: 19395470 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.

  PMID: 15634833 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.

  PMID: 21248211 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.

  PMID: 7605612 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.

  PMID: 26942474 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.

  PMID: 25944156 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.

  PMID: 20554319 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.

  PMID: 23651507 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.

  PMID: 21999623 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.

  PMID: 16470437 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.

  PMID: 23614539 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.

  PMID: 24799144 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.

  PMID: 8515007 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.

  PMID: 7430595 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.

  PMID: 23660061 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.

  PMID: 12945647 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.

  PMID: 15891987 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.

  PMID: 8773720 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.

  PMID: 21159335 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.

  PMID: 17168270 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.

  PMID: 27418884 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.

  PMID: 9840793 BACKGROUND

MeSH Terms

Conditions

Tendon Injuries

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hand Surgery Unit Director, Rabin Medical Center

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 26, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: within 6 months of study completion
• Access Criteria: requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.