Amputation; Traumatic, Hand
Conditions
Keywords
Replantation, Revascularization, Unfractionated heparin, Finger
Brief summary
The purpose of this study is to determine the effectiveness of therapeutic dose intravenous heparin at improving replantation/revascularization success and its indications (if any) in participants who have suffered traumatic digital amputation. Digital replantation/revascularization success will be assessed in participants who receive continuous intravenous drip of thromboprophylactic heparin at a therapeutic dose (i.e. modifies INR to the desired range) contrasted to those who do not receive therapeutic dose heparin (i.e. does not modify INR to the desired range). In the study, replantation/revascularization success is defined as a clearly viable digit at the time of discharge. Secondary objectives include assessing postoperative complications associated with heparin use, such as bleeding, hematoma or heparin induced thrombocytopenia. The investigators would also assess the impact of categorical variables such as smoking status, mechanism of injury and comorbidities, on digital survival.
Interventions
DRUGIntravenous unfractionated heparin
See experimental arm description for intervention description.
DRUGSham
See sham comparator arm description for intervention description.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective randomized double-blinded clinical trial
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal
Exclusion criteria
* Patients on anticoagulants, other than ASA, prior to admission (i.e. Coumadin, Eliquis, Pradaxa, Plavix, or similar medications) * Patients with a contraindication for heparin (e.g. coagulopathy, acute ulcers, thrombocytopenia, severe liver damage, shock) * Patients who suffered an amputation in the level of the carpal tunnel and proximal to it * Patients who experienced a degloving injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of digit replantation or revascularization | Up to 14 days | Success is defined as a clearly viable digit, determined by saturation with a pulse oximeter or by bleeding on needle pinprick. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heparin-related complications | Up to 14 days | Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia. |
Countries
Canada
Contacts
CONTACTLinda M Zhu
PRINCIPAL_INVESTIGATORBruno Mastropasqua, MD FRCSC
Université de Montréal
Outcome results
None listed