The Effect of Human Albumin on Coagulation Competence and Hemorrhage
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|ClinicalTrials.gov Identifier: NCT02270723|
Recruitment Status : Unknown
Verified October 2014 by Kirsten Cleemann Rasmussen, Rigshospitalet, Denmark.
Recruitment status was: Enrolling by invitation
First Posted : October 21, 2014
Last Update Posted : October 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhage; Complicating Delivery, Coagulation Defect||Drug: 5% Human Albumin " Behring" Drug: Lactated Ringer||Phase 4|
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.
|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 :||August 2014|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||November 2015|
Active Comparator: Human Albumin " Behring"
Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Drug: 5% Human Albumin " Behring"
Intravenous infusion of 5% Human Albumin during major surgery
Other Name: Human Albumin
Placebo Comparator: Lactated Ringer
Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Drug: Lactated Ringer
Intravenous infusion of Lactated Ringer during major surgery
Other Name: Ringer
- Measurement of coagulation during surgery and in the recovery room [ Time Frame: up to 1 day after surgery ]Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude
- Measurement of postoperative surgical complications [ Time Frame: 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 [ Time Frame: up to 1 day after surgery ]Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270723
|Copenhagen, Denmark, 2100|
|Study Chair:||Niels H Secher, MD PHD Prof||Rigshospitalet, University of Copenhagen|