Hemorrhage; Complicating Delivery, Coagulation Defect
Conditions
Brief summary
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
Detailed description
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.
Interventions
DRUG5% Human Albumin Behring
Intravenous infusion of 5% Human Albumin during major surgery
DRUGLactated Ringer
Intravenous infusion of Lactated Ringer during major surgery
Sponsors
Kirsten Cleemann Rasmussen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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 nonsteroidal antiinflammatory drug 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 to Human Albumin * Disturbance in electrolytes * Patient under committee * Patient joining another trial interfering the actual trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of coagulation during surgery and in the recovery room | up to 1 day after surgery | Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of postoperative surgical complications | From date of operation up to 1 months postoperatvely | Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation |
| Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room | up to 1 day after surgery | Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin |
Countries
Denmark
Outcome results
None listed