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Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization

StatusRecruiting
PhasePhase 4
Started2021-05-24
View on ClinicalTrials.gov ↗

Amendment history

2026-03-27
minor
Study Status v7
Primary completion date2024-09-24→2027-03-01
Completion date2025-05-01→2027-05-01
2023-07-25
minor
Study Status v6
Primary completion date2023-05-24→2024-09-24
Completion date2023-09-01→2025-05-01
2022-08-01
minor
Study Status v5
Primary completion date2022-05-24→2023-05-24
Completion date2022-09-01→2023-09-01
2021-05-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2021-05-10
minor
Study Status v3
Primary completion date2022-05-01→2022-05-24
Start date2021-05-01→2021-05-24
Show 2 earlier versions
2021-04-07
minor
Study Status v2
Primary completion date2022-03-01→2022-05-01
Start date2021-03-01→2021-05-01
2021-01-28
minor
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2021-01-24
minor
Original filing
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.
Trial Details
NCT Number NCT04725201
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Amputation; Traumatic, Hand
Enrollment 188 participants
Start Date 2021-05-24
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-02