Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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:
- Study Group - Intra-venous Tranexamic acid treatment
- 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
Exclusion criteria
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Age < 18
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Pregnant Women
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Patients that presented 3 weeks or later after the injury
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Medical history positive for Rheumatic disease
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Current active treatment with anti-coagulation medications
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Injury to more than one finger
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Presence of a fracture in the affected finger
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Presence of a nerve injury in the affected finger that won't enable early use and activation in early rehabilitation protocol
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Mangled extremity injury, degloving injury or other soft tissue injuries that won't enable primary closure of skin
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Previous tear of the affected tendon
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Degenerative tear of flexor tendon
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Tendon tear secondary to infection
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Previous injuries to contralateral side causing dysfunction and/or decreased fingers' range of motion
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Contraindications to Tranexamic acid treatment:
- Known hypersensitivity to tranexamic acid or to any other ingredient of the preparation.
- Patients with thromboembolic disease.
- Patients with active intravascular clotting.
- Severe renal failure because of risk of accumulation.
- Patients with subarachnoid hemorrhage
- Patients with acquired defective color vision
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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