Use of Bemiparine as a Prophylactic Antitrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To compare the use of Bemiparine, against Clexane as an antithrombotic agent
研究概览
简要总结
A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction.
详细描述
This is an observational post-authorization study on a group of patients undergoing microsurgery on the Oral and Maxillofacial Surgery and Plastic and Reconstructive Surgery Service at Ramon y Cajal Hospital, Madrid for processes that require reconstruction with a flap microvascular. A group of 67 patients treated according protocol postoperative prevention of deep vein thrombosis with Bemiparina will be compared with data collected retrospectively from a group of 134 patients treated previously with an earlier protocol with enoxaparin as main antithrombotic agent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that will undergo reconstructive surgery for defects in any part of the body, especially in head and neck, after cancer, traumatic or infectious pathology, which will require the use of techniques of microsurgery.
- •Patients who have given their informed consent
- •Patients in which it has been decided to use thromboprophylaxis with bemiparina before proposing them to participate in the study.
排除标准
- •Patients not eligible for repair through the use of free flaps, and therefore the use of Microsurgical techniques for vascular anastomosis
- •Patients with an underlying pathology that may interfere to a clinically significant or contraindicated the use of Bemiparina, such as: serious hepatic or renal insufficiency, uncontrolled arterial hypertension, history of gastroduodenal, thrombocytopenia, nephrolithiasis or uretrolitiasis and vascular disease ulcer of choroid and retina.
- •Refusal of the patient or their family members to participate in the study.
- •Pregnancy and breastfeeding
- •Known hypersensitivity to study drugs or any of its components
研究组 & 干预措施
Prospective Cohort
Patients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis
干预措施: Bemiparine (Drug)
结局指标
主要结局
To compare the use of Bemiparine, against Clexane as an antithrombotic agent
时间窗: 24 months
Incidence thrombotic complications and bleeding
次要结局
- Incidence of deep vein thrombosis and pulmonary embolism(24 months)
- Incidence of postsurgery hemorrhagic strokes with both drugs(24 months)