Effect of Colloid Versus Crystalloid on Coagulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Bloodloss

Intervention / Treatment
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* Drug: Ringer-lactate SAD
* Drug: HES 130/04


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 NSAID 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 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: crystalloid<br> | Drug: Ringer-lactate SAD<br>* Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.<br>* Other names: Ringer-laktat SAD, B 05 BB 01, Amgros A/S.;|
| Placebo Comparator: colloid<br> | Drug: HES 130/04<br>* Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate SAD.<br>* Other names: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of colloid versus crystalloid on laboratory coagulation. | 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. | 5-7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of colloid versus crystalloid on the amount of bloodloss | The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on. | 5-7 hours |