The Effect of Human Albumin on Coagulation Competence and Hemorrhage

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhage; Complicating Delivery, Coagulation Defect
• Intervention / Treatment: Drug: 5% Human Albumin " Behring"; Drug: Lactated Ringer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Ringer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of coagulation during surgery and in the recovery room	Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude	up to 1 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of postoperative surgical complications	Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation	From date of operation up to 1 months postoperatvely
Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room	Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin	up to 1 day after surgery

Collaborators and Investigators

• Sponsor: Kirsten Cleemann Rasmussen
• Investigators: Study Chair: Niels H Secher, MD PHD Prof, Rigshospitalet, University of Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: September 27, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
• Other Study ID Numbers: COL18