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

NCT ID: NCT04178655

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2023-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid Treatment

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

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

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

Interventions

Tranexamic acid injection

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

Intervention Type: DRUG

PLACEBO

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sorin Daniel Iordache

Hand Surgery Unit Director, Rabin Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Other Identifiers

0219-19-RMC

Identifier Type: -

Identifier Source: org_study_id