The Effect of Human Albumin on Coagulation Competence and Hemorrhage

Study Overview
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Brief Summary
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In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.

Detailed Description
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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.

Official Title
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Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Conditions
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Hemorrhage; Complicating Delivery, Coagulation Defect

Intervention / Treatment
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* Drug: 5% Human Albumin  Behring
* Drug: Lactated Ringer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human Albumin  Behring<br>Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours | Drug: 5% Human Albumin  Behring<br>* Intravenous infusion of 5% Human Albumin during major surgery<br>* Other names: Human Albumin;|
| Placebo Comparator: Lactated Ringer<br>Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours | Drug: Lactated Ringer<br>* Intravenous infusion of Lactated Ringer during major surgery<br>* Other names: Ringer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of coagulation during surgery and in the recovery room | Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude | up to 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of postoperative surgical complications | Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation | From date of operation up to 1 months postoperatvely | 
| Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room | Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin | up to 1 day after surgery |