Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Success of digit replantation or revascularization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal
排除标准
- •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
研究组 & 干预措施
Intravenous unfractionated heparin
Administration of intravenous unfractionated heparin according to the Centre hospitalier de l'Université de Montréal (CHUM) deep vein thrombosis (DVT) protocol for 5 days after vascular anastomosis. A bolus will be administered intraoperatively based on the patient's weight. Dosages will be adjusted according to the activated partial thromboplastin time (aim for an APTT of 50-70), which will be measured 6 hours after the start of the protocol and after every dosage adjustment or every morning at 6 a.m. if no adjustments were made in the last 6 hours.
干预措施: Intravenous unfractionated heparin (Drug)
Control
No administration of intravenous unfractionated heparin. These patients receive 5000 IU BID of heparin subcutaneously, as a standard post-operative protocol for all in-patients.
The control group receives sham bolus intraoperatively of normal saline and a post-operative normal saline infusion at a fixed dose through an infusion pump to mimic IV heparin infusion.
干预措施: Sham (Drug)
结局指标
主要结局
Success of digit replantation or revascularization
时间窗: 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.
次要结局
- Heparin-related complications(Up to 14 days)