Effect of Colloid Versus Crystalloid on Coagulation
|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|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444508
|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|