Hemorrhage; Complicating Delivery, Coagulation Defect Clinical Trial
Official title:
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether
affected coagulation competence induced by Human Albumin leads to a significant
perioperative blood loss when compared to administration of lactated Ringer´s solution.
Data are gathered by the investigators, analysed by the sponsor, and remain confidential
throughout the process. The investigators shall be involved in all stages of the study
development and vouch for the completeness and accuracy of the data. No third part shall
influence the protocol, trial conduct, data analysis, or reporting.
The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial
pressure, cardiac output are measured after induction of anaesthesia and insertion of the
arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after
resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours
thereafter in the recovery room (T4).
Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot
initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30)
depicting haemostatic competence (thrombelastography). The investigators analyze blood for
haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the
central venous catheter for lactate and blood gas variables (ABL 825, Radiometer,
Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive
lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated
fluid (non-study fluid).
The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of
surgery, and two hours thereafter. The investigators register complications postoperatively
inclusive hospital stay until discharge.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment