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Trial record 11 of 426 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT04178655
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sorin Daniel Iordache, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 26, 2019
Last Update Posted Date November 26, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
Anatomic Result at 4-Months post-operatively [ Time Frame: Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2019)
  • Anatomic Result at 2-weeks and 8-weeks post-operatively [ Time Frame: 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. ]
    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 to each post-operative follow up will be recorded.
  • Extent of finger and hand swelling [ Time Frame: 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. ]
    Estimation of finger and hand swelling will be achieved by calculating a Swelling-Ratio (SR). Direct measurement of the circumference of both the affected and unaffected finger and hand palm will be made. Finger circumference will be measured in two anatomic locations: the middle of both the proximal and middle phalanx. Hand circumference will be measured on the level of the distal palmar crease. Above measurements will be documented in centimeters. The SR will be calculated by dividing the circumference of the affected side by the circumference of the unaffected side.
  • Strength Result [ Time Frame: 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. ]
    Grip Strength is a widely-used clinical assessment tool , which gives a good global assessment of muscle strength, and delineates the impact of tendon injury on overall strength. After flexor tendon repair, impairments are more common in isolated finger flexion than in overall handgrip strength. overall grip strength is the mainstay of strength assessment. There are several standardized protocols to assess grip strength, one is performing the measurement with the elbow flexed 90 degrees, the forearm in neutral, and the Patient gripping the Jamar dynamometer at the second handle position. Estimation of hand grip strength will be achieved by calculating a Grip Strength-Ratio (GSR). Direct measurement of the Grip strength of both the affected and unaffected hands will be made. Above measurements will be documented in kilograms. The GSR will be calculated by dividing the grip strength of the affected hand by the grip strength of the unaffected side.
  • Functional Result - DASH Score [ Time Frame: 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 Evaluation will be achieved using the DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire. The DASH Score is the current most practiced scale for upper extremity functionality, and was extensively validated in numerous studies. The Scale ranges from 0 (no disability) to 100 (most severe disability).
  • Functional Result - PRWE Score [ Time Frame: 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 Evaluation will be achieved using the PRWE (Patient-Rated Wrist Evaluation) Questionnaire. The PRWE was originally developed in 1998 as a measure of patient-rated pain and disability, following Distal Radius or Scaphoid Fractures. The Scale ranges from 0 (no disability) to 100 (most severe disability).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tendon Injury - Hand
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Tranexamic Acid Treatment
    1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
    Intervention: Drug: Tranexamic acid injection
  • Placebo Comparator: Placebo
    10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
    Intervention: Drug: PLACEBO
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04178655
Other Study ID Numbers  ICMJE 0219-19-RMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Sorin Daniel Iordache, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP