NCT04178655

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

Range of Motion and Function Following Primary Repair of Traumatic Zone 1 or Zone 2 Digit Flexor Tendon Injuries - Impact of Tranexamic Acid Use - A Prospective Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

Detailed description

Peritendinous adhesions following repair of digital flexor tendons are a major postoperative complication, due to loss of motion and the functional disability that they cause. Patients who will present to Rabin Medical Center with acute traumatic Zone 1 or Zone 2 Digit flexor tendon injury, will be recruited to the study, given the patients' informed consent. Patients recruited to the study will be randomly assigned to either the study group or control group: 1. Study Group - Intra-venous Tranexamic acid treatment 2. Control Group - Placebo (Intra-venous normal saline 0.9%) All patients will be treated operatively with primary repair of the lacerated flexor tendon. All patients will be treated post-operatively with early controlled mobilization according to the Duran Protocol. Randomization of the patients will take place before surgery, in the following manner: half of the study population will be treated with IV Tranexamic Acid , the other half will be treated with or IV Normal Saline as Placebo. Either Tranexamic Acid or IV Normal Saline will be administered by the anesthesiologist present in the operating room, prior to tourniquet inflation. Each patient will be assigned a serial number, and 2 envelopes allocated to that serial number will be prepared in advance. The first envelope will be attached to the patient's file, and be given only to the anesthesiologist in the operating room. The second envelope assigned to the patient will remain closed until the end of the study, along with the study's documents. All study patients and hand surgeons will be blinded to the treatment received by the study population. Post-Operative measurements will be made by an orthopedic surgeon or occupational therapist, which will also be blinded to the treatment received by the study population. To ensure confidentiality, all study documents and data will be kept inside a locked closet, in a locked room in the orthopedic department

Conditions

• Tendon Injury - Hand

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
DRUG	PLACEBO	10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-11-01
• Completion: 2023-03-01
• First posted: 2019-11-26
• Last updated: 2019-11-26