Effect of colloid versus crystalloid on coagulation in elective urological surgery. A randomised clinical trial.

INTERVENTION: Trade Name: Ringers Lactat Pharmaceutical Form: Solution for infusion Trade Name: Voluven Pharmaceutical Form: Solution for infusion CONDITION: Neoplasma malignum vesicae urinariae ; MedDRA version: 14.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To investigate if coagulation and loss of blood during the operation depends on the type of liquid usen to keep the patient normovolaemic estimated by optimizing cardiac output. Primary end point(s): To estimate coagulation during operation when the patient is normovolaemic Secondary Objective: Timepoint(s) of evaluation of this end point: After infusion, end of operation and two hours later SECONDARY OUTCOME: Secondary end point(s): estimate the amount of blood loss and need for transfusion Timepoint(s) of evaluation of this end point: end of operation and two houra later INCLUSION CRITERIA: Patienter over 18 år med indikation for elektiv postrenal aflastende operation med cystektomi. Hvis patienten er i antikoagulationsbehandling skal der være holdt pause med AK‐behandling, ASA‐ og NSAID præparater i 5 dage. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20