Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of colloid versus crystalloid on laboratory coagulation.
研究概览
简要总结
In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Patient more than 18 years old
- •Indication for elective post-renal operation including cystectomy
- •Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.
排除标准
- •Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
- •Pregnant or nursing
- •Disturbance in electrolytes
- •Patient under committee
- •Patient joining another trial interfering the actual trial.
研究组 & 干预措施
crystalloid
干预措施: Ringer-lactate "SAD" (Drug)
colloid
干预措施: HES 130/04 (Drug)
结局指标
主要结局
Effect of colloid versus crystalloid on laboratory coagulation.
时间窗: 5-7 hours
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.
次要结局
- Effect of colloid versus crystalloid on the amount of bloodloss(5-7 hours)
研究者
K. C. Rasmussen
MD, specialist in surgery and research fellow
Rigshospitalet, Denmark