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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
See experimental arm description for intervention description.
See sham comparator arm description for intervention description.
CHUM
Montreal, Quebec, Canada
RECRUITINGSuccess of digit replantation or revascularization
Success is defined as a clearly viable digit, determined by saturation with a pulse oximeter or by bleeding on needle pinprick.
Time frame: Up to 14 days
Heparin-related complications
Complications include but are not limited to bleeding at or away from site of injury, hematoma, heparin-induced thrombocytopenia.
Time frame: Up to 14 days
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