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
- Measurement of coagulation during surgery and in the recovery room
研究概览
简要总结
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
详细描述
5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether affected coagulation competence induced by Human Albumin leads to a significant perioperative blood loss when compared to administration of lactated Ringer´s solution.
Data are gathered by the investigators, analysed by the sponsor, and remain confidential throughout the process. The investigators shall be involved in all stages of the study development and vouch for the completeness and accuracy of the data. No third part shall influence the protocol, trial conduct, data analysis, or reporting.
The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial pressure, cardiac output are measured after induction of anaesthesia and insertion of the arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours thereafter in the recovery room (T4).
Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30) depicting haemostatic competence (thrombelastography). The investigators analyze blood for haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the central venous catheter for lactate and blood gas variables (ABL 825, Radiometer, Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated fluid (non-study fluid).
The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of surgery, and two hours thereafter. The investigators register complications postoperatively inclusive hospital stay until discharge.
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
- 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 nonsteroidal antiinflammatory drug
- •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
- •Allergic to Human Albumin
- •Disturbance in electrolytes
- •Patient under committee
- •Patient joining another trial interfering the actual trial
研究组 & 干预措施
Human Albumin " Behring"
Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
干预措施: 5% Human Albumin " Behring" (Drug)
Lactated Ringer
Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
干预措施: Lactated Ringer (Drug)
结局指标
主要结局
Measurement of coagulation during surgery and in the recovery room
时间窗: up to 1 day after surgery
Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude
次要结局
- Measurement of postoperative surgical complications(From date of operation up to 1 months postoperatvely)
- Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room(up to 1 day after surgery)
研究者
Kirsten Cleemann Rasmussen
MD, Specialist in Surgery
Rigshospitalet, Denmark