Clinical role of human albumin in extracorporeal prime

ISRCTN ISRCTN80847914
DOI https://doi.org/10.1186/ISRCTN80847914
Secondary identifying numbers N/A
Submission date
09/02/2012
Registration date
21/02/2012
Last edited
23/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims?
Due to it being difficult to operate on a beating heart, a heart-lung machine is used to take over for the heart and lungs during open-heart surgery. Starches and/or human albumin are often added to the fluid used to set up the machine before surgery. Human albumin and starch are quite similar in what they do. However, unlike starch, human albumin is a protein found in human blood and it helps to limit any reactions between the blood circulating around the heart-lung machine and the materials that the machine is made from (biopassivation). The passivation effect of albumin has been known to be good for patients having open-heart surgery, but there has been very little research to support its continued use. We want to assess whether not using human albumin in the heart-lung machine has any effect on the care of the patient.

Who can participate?
This study is open to all patients having uncomplicated coronary artery bypass surgery at Eastern Health in St. John’s, Newfoundland, Canada, between 18 and 70 years of age.

What does the study involve?
After informed consent, an investigator will draw a lottery ticket when the patient arrives in the operating room. This will randomly select the patient to one of 2 groups. Group 1 receives the starch, group 2 the human albumin. There will be a few extra blood samples taken during the surgery. These blood samples will be taken while the patient is asleep, and will not require any extra needle sticks to obtain them. This study will take place during the surgery in the operating room. One number will be taken from the patients chart 24 hours after the surgery. The results from these extra blood tests are not available to any clinician to affect treatment while in hospital, and will only be used for this study.

What are the possible benefits and risks of participating?
Both the fluids that we are looking at in this study are used in some combination in essentially every hospital in Canada that performs open-heart surgery. One fluid, human albumin 5% USP, is a fluid made from donated human plasma. As a result, this fluid may contain viruses or other agents that can cause infection and illness. However, the manufacturing process is specifically designed to reduce these agents, if they are present. This risk is very rare. The other fluid, Voluven 6%, is a fluid made from cornstarch. This fluid may cause mild pruritus (itching skin) in approximately one out of ten people receiving it, which may appear between one and six weeks after exposure, and last for several weeks to months. This fluid may also cause rare anaphylactic allergic reactions. There are no known additional risks caused by adding both these fluids at the same time. There are no anticipated benefits for the individual patient participating in this study.

Where is the study run from
Eastern Health, Memorial University (Canada)

When is study starting and how long is it expected to run for?
From September 2009 to September 2010

Who is funding the study?
Fresenius Kabi (Canada)

Who is the main contact?
Dr. Chander Kamra
ckamra@mun.ca

Contact information

Dr Chander Kamra
Scientific

Discipline of Anesthesia, Eastern Health
Memorial University
300 Prince Philip Drive
St. John's
A1B 3V6
Canada

Study information

Study designSingle-blinded single-center randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProspective randomized controlled trial of human albumin in biopassivation of extracorporeal circuits
Study objectivesHuman albumin is commonly used in extracorporeal prime to provide oncotic pressure to the priming fluid. Another less described indication is its ability to coat the surfaces of the extracorporeal circuit with a protein monolayer, providing biopassivation. Whether this biopassivation has clinically relevant effects is considered.
Ethics approval(s)Human Investigation Committee, Memorial University (Canada), 17/09/2009, ref. 09.170
Health condition(s) or problem(s) studiedCoronary Artery Disease
InterventionPatients are randomized with a lottery draw into two groups, Control Group and Study Group.

Surgical procedure is identical in both groups, except patients in the Study Group are to receive 50 mL Human Albumin 5% (Plasbumin 5, Talecris Biotherapeutic Ltd., Mississauga, ON), and patients in the Control Group receive 50 mL Plasma-Lyte A in to the heart lung machine.

No further albumin or Voluven 6% is added during the pre-operative or extracorporeal support period. To minimize perfusion conduct variances, one perfusionist will perform the cases.

Blood samples are obtained from the heart lung machine, or in dwelling arterial lines, during the surgery.

The study period will consist of the time the patient is in the operating room, typically four to six hours, and data collection will continue until 24 hours post-operative.
Intervention typeOther
Primary outcome measure1. Arterial blood samples are obtained at three intervals. After induction (Prebypass), 30 minutes after bypass initiation (During), and 15 minutes after protamine administration (Postbypass). All samples are assayed within one hour of collection.
2. Total disaggregated platelet counts are measured with an LH750 analyzer (Beckman Coulter, Mississauga, ON) using whole blood collected in 7.2 mg K2 EDTA blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ)
3. Platelet function is measured with a Dade Behring PFA¨C100 analyzer (Newark, DE, USA) using whole blood collected in 0.105 mol/L sodium citrate blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ). Two assays are run for each sample, one using a collagen/epinephrine (Col/EPI) cartridge, and one with a collagen/adenosine (Col/ADP) cartridge. The PFA¨C100 assay requires a reasonable hematocrit to return valid results, therefore patients with hematocrits falling below 25% are excluded from the study
4. A total 24-hour total chest tube drainage value is obtained by measuring the total chest tube drainage 24 hours after entry to the intensive care unit
Secondary outcome measures1. Demographic information including age, sex, weight are collected
2. Extracorporeal support times and cross clamp times, and urine production
Overall study start date17/09/2009
Completion date17/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsTotal target number of completed participants is 20
Key inclusion criteria1. Male or female between 18 and 70 years of age
2. Any patient presenting for first time, uncomplicated coronary artery bypass surgery at the institution where the study is being performed
Key exclusion criteria1. Age > 70 years
2. Graft number less than two or more than six
3. Coexistent cardiac disease
4. Re-operation
5. Emergent surgery
6. Pre-operative inotropic support
7. Pre-operative intraaortic balloon pump insertion, or
8. Any deviation from the study protocol
Date of first enrolment17/09/2009
Date of final enrolment17/09/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

Discipline of Anesthesia, Eastern Health
St. John's
A1B 3V6
Canada

Sponsor information

Memorial University (Canada)
Hospital/treatment centre

c/o Dr. Chander Kamra
Clinical Associate Professor
Discipline of Anesthesia, Eastern Health
300 Prince Philip Drive
St. John's
A1B 3V6
Canada

ROR logo "ROR" https://ror.org/04haebc03

Funders

Funder type

Industry

Fresenius Kabi (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2013 Yes No