Effect of Colloid Versus Crystalloid on Coagulation
|ClinicalTrials.gov Identifier: NCT01444508|
Recruitment Status : Unknown
Verified December 2013 by K. C. Rasmussen, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : September 30, 2011
Last Update Posted : December 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bloodloss||Drug: Ringer-lactate "SAD" Drug: HES 130/04||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||December 2013|
|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.
- Effect of colloid versus crystalloid on laboratory coagulation. [ Time Frame: 5-7 hours ]
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 ]The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444508
|Contact: Niels H Secher, Professor||+45 3545 firstname.lastname@example.org|
|Contact: Kirsten C Rasmussen, MD||+45 61335239 ext +45 email@example.com|
|Copenhagen, Denmark, 2100|
|Contact: Niels Henry Secher, Professor +45 35452242 firstname.lastname@example.org|