Condition category
Circulatory System
Date applied
09/02/2012
Date assigned
21/02/2012
Last edited
23/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chander Kamra

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prospective randomized controlled trial of human albumin in biopassivation of extracorporeal circuits

Acronym

Study hypothesis

Human 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

Human Investigation Committee, Memorial University (Canada), 17/09/2009, ref. 09.170

Study design

Single-blinded single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary Artery Disease

Intervention

Patients 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 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 measures

1. Demographic information including age, sex, weight are collected
2. Extracorporeal support times and cross clamp times, and urine production

Overall trial start date

17/09/2009

Overall trial end date

17/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total target number of completed participants is 20

Participant exclusion criteria

1. 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

Recruitment start date

17/09/2009

Recruitment end date

17/09/2010

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

Memorial University (Canada)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Fresenius Kabi (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23771563

Publication citations

  1. Results

    Kamra C, Beney A, Human albumin in extracorporeal prime: effect on platelet function and bleeding., Perfusion, 2013, 28, 6, 536-540, doi: 10.1177/0267659113492836.

Additional files

Editorial Notes