NCT00866268已完成3 期
"Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau4 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 4
- 主要终点
- total post-surgical blood loss (mL)
研究概览
简要总结
Principal hypothesis:
A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.
详细描述
Secondary's hypothesis:
- It don't expect differences in:
- Incidence of hematomas
- Incidence in surgery wound infection
- Time of immobilization
- Duration of hospitalization
- The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult knee replacement patients who agreed to participate in the study
排除标准
- •People that not accomplished the inclusion criteria
结局指标
主要结局
total post-surgical blood loss (mL)
时间窗: from the moment after surgery until drainage catheter removal
次要结局
- mortality(10 days)
- adverse reactions(10 days)
- blood loss (mL) in the recovery unit(24-48 h)
- Blood loss in the ward(5-10 days)
- need for a blood transfusion according to the surgeon's criteria(10 days)
- number of blood units required for transfusion(10 Days)
- post-surgical pain (using a 100mm visual analogue scale)(10 days)
- incidence of hematomas(10 days)
- infections(10 days)
- hypotension(10 days)
- suture dehiscence(10 days)
- re-intervention due to complications in the surgical wound(10 dasy)
- venous thrombosis(10 days)
研究者
研究点 (4)
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