The Effect of Human Albumin on Coagulation Competence and Hemorrhage

NCT ID: NCT02270723

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

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.

Conditions

Hemorrhage; Complicating Delivery, Coagulation Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Human Albumin " Behring"

Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours

Group Type: ACTIVE_COMPARATOR

5% Human Albumin " Behring"

Intervention Type: DRUG

Intravenous infusion of 5% Human Albumin during major surgery

Lactated Ringer

Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours

Group Type: PLACEBO_COMPARATOR

Lactated Ringer

Intervention Type: DRUG

Intravenous infusion of Lactated Ringer during major surgery

Interventions

5% Human Albumin " Behring"

Intravenous infusion of 5% Human Albumin during major surgery

Intervention Type: DRUG

Lactated Ringer

Intravenous infusion of Lactated Ringer during major surgery

Intervention Type: DRUG

Other Intervention Names

Human Albumin; Ringer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirsten Cleemann Rasmussen

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Cleemann Rasmussen

MD, Specialist in Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Niels H Secher, MD PHD Prof

Role: STUDY_CHAIR

Rigshospitalet, University of Copenhagen

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Mar;95(9):e2720. doi: 10.1097/MD.0000000000002720.

Reference Type: DERIVED

PMID: 26945358 (View on PubMed)

Other Identifiers

COL18

Identifier Type: -

Identifier Source: org_study_id