In a small pilot study to investigate possible occurence of blood chemistry deviations and / or a tamponade after the application of ACF-Matrix haemostat in the (L)IMA bed.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- the possible occurrence of abnormalities in blood chemistry
- the possible occurrence of tamponade
Secondary outcome
n.a.
Background summary
Haemostatic gelatin sponges in general have not been applied in the (L)IMA bed
during CABG opartaions, nor has the haemostatic gelatin sponge ACF-Matrix
haemostat in particular been applied in these operations.
Haemostatic gelatin sponges have succesfully and without (major) side effects
been applied in over 100 million operations over the last 10 years.
Nevertheless, we are of the opinion that a small pilot study to investigate
possible occurence of blood chemistry deviations and / or a tamponade after the
application of ACF-Matrix haemostat is appropriate.
Study objective
In a small pilot study to investigate possible occurence of blood chemistry
deviations and / or a tamponade after the application of ACF-Matrix haemostat
in the (L)IMA bed.
Study design
10 patients that have to undergo an elective CABG operation will be asked by
the outpatient doctor to participate in this study. If they agree, 1 day before
the operation the patients will have to sign an Informed Consent form.
During the (routine) operation, the only deviation form the hospital protocol
will be the application of ACF-Matrix haemostat in the (L)IMA-bed. All other
procedures are according to the hospital protocol.
12 -24 hours after the operation, (routine) blood chemistry will be assessed to
investigate if any abnormalities can be found.
In order to recognise signs and symptoms of tamponade within the first 28 days
post operative, it will be explained to patients what these signs and symptoms
can be: hypotension, tachycardia, tachypnea, distended neck veins, cool
extremities with diminished peripheral pulses, decreased urine output and
restlessness. In case patients suspects they have 1 or more of these symptoms,
they are advised to immediately contact the hospital.
Intervention
ACF-Matrix haemostat is a gelatin sponge with haemostatic action and will be
applied in the (L)IMA-bed after removal of the "donor" artery.
Study burden and risks
The expected burden for the patient is minimal. When, as expected, there will
be no signs of tamponade, the total burden in time will be approximately 45
minutes.
The risk for the patient of the application of ACF-Matrix haemostat is expected
to be minimal since in the past decade over 100 million haemostatische gelatine
sponges have been applied successfully in several surgical indications without
giving rise to any (major) side effects.
Osdorperweg 590
1067 SZ Amsterdam
Nederland
Osdorperweg 590
1067 SZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Patients 18 years of age or older;
- Patients showing signs and symptoms of coronary ischemia and/or stenosis who are clinically fit to undergo a CABG operation;
- The investigator is satisfied patients have no other ailments that could prevent patients from finishing the study.
Exclusion criteria
- Patients requiring an acute CABG operation;
- Patients partcipating in another clinical trial;
- Patients with a local or systemic infection requiring intravenous administration of antibiotics;
- Patients with an allergy to porcine products
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25911.068.08 |