Bloodloss
Conditions
Brief summary
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.
Interventions
DRUGRinger-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.
DRUGHES 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.
Sponsors
K. C. Rasmussen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colloid versus crystalloid on laboratory coagulation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colloid versus crystalloid on the amount of bloodloss | 5-7 hours | The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on. |
Countries
Denmark
Contacts
Primary ContactNiels H Secher, Professor
Backup ContactKirsten C Rasmussen, MD
Outcome results
None listed