Tendon Injury - HandEarly Phase 1NCT04178655
Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
A Early Phase 1 study testing Tranexamic acid injection in people with Tendon Injury - Hand, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official title: 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
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.
Read the 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:
- 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
- Conditions
- Tendon Injury - Hand
- Being tested
- Tranexamic acid injection, PLACEBO
- Keywords
- Tendon Injury, Tranexamic Acid
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
PLACEBODrug
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Treatment | Experimental | 1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION Receives: Drug: Tranexamic acid injection |
| Placebo | Placebo comparator | 10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Tendon Injury - HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sorin Daniel Iordache, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178655
- Sponsor's protocol ID
- 0219-19-RMC
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available
Publications
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.
PubMed 25934203Legrand 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.
PubMed 28709791Khanna 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.
PubMed 19395470Sharma 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.
PubMed 15634833Ishiyama 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.
PubMed 21248211Murphy 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.
PubMed 7605612Lin 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.
PubMed 26942474Aguilera 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.
PubMed 25944156CRASH-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.
PubMed 20554319Gandhi 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.
PubMed 23651507McConnell 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.
PubMed 21999623Niskanen 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.
PubMed 16470437Oremus 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.
PubMed 23614539Frueh 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.
PubMed 24799144Jansen 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.
PubMed 8515007
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04178655
- Acronym / sponsor ID
- 0219-19-RMC
- Conditions
- Tendon Injury - Hand
- Keywords
- Tendon Injury, Tranexamic Acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Treatment | Experimental | Drug: Tranexamic acid injection1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION |
| Placebo | Placebo comparator | Drug: PLACEBO10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injection1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION | Drug | Tranexamic Acid Treatment |
| PLACEBO10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Background: PubMed 25934203Pulos 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.
- Background: PubMed 28709791Legrand 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.
- Background: PubMed 19395470Khanna 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.
- Background: PubMed 15634833Sharma 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.
- Background: PubMed 21248211Ishiyama 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.
- Background: PubMed 7605612Murphy 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.
- Background: PubMed 26942474Lin 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.
- Background: PubMed 25944156Aguilera 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.
- Background: PubMed 20554319CRASH-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.
- Background: PubMed 23651507Gandhi 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.
- Background: PubMed 21999623McConnell 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.
- Background: PubMed 16470437Niskanen 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic acid injection in people with Tendon Injury - Hand, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178655, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.