Effect of Colloid Versus Crystalloid on Coagulation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery|
- Effect of colloid versus crystalloid on laboratory coagulation. [ Time Frame: 5-7 hours ] [ Designated as safety issue: No ]
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.
- Effect of colloid versus crystalloid on the amount of bloodloss [ Time Frame: 5-7 hours ] [ Designated as safety issue: No ]The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: crystalloid||
Drug: Ringer-lactate "SAD"
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.
Other Name: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
|Placebo Comparator: colloid||
Drug: HES 130/04
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".
Other Name: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.
|Contact: Niels H Secher, Professor||+45 3545 email@example.com|
|Contact: Kirsten C Rasmussen, MD||+45 61335239 ext +45 firstname.lastname@example.org|
|Copenhagen, Denmark, 2100|
|Contact: Niels Henry Secher, Professor +45 35452242 email@example.com|