NCT01373801Unknown不适用
THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Cessation of bleeding after a 30 minutes
研究概览
简要总结
The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Age≥18 year
- •Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration
排除标准
- •Subjects undertaking anticoagulation treatment
- •Pre-existing coagulopathy
- •Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
- •Systolic blood pressure <90mmHg
- •Shellfish allergy
研究组 & 干预措施
Control
Active Comparator
干预措施: The HemCon GuardaCare (Device)
Control
Active Comparator
干预措施: Control (Device)
GuardaCare
Experimental
干预措施: The HemCon GuardaCare (Device)
结局指标
主要结局
Cessation of bleeding after a 30 minutes
时间窗: 30 minutes
The primary endpoint is a cessation of bleeding after a 30 minute period. Evaluation of bleeding will be performed by an independent evaluator, who will determine if the bleeding has stopped.
次要结局
- Procedural success(6 hours)
- Safety composite endpoint(7 days)
- Device Success(6 hours)
研究者
研究点 (1)
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