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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1670 |
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Date of registration:
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12/02/2009 |
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Primary sponsor: |
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Public title:
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TripleFive Pilot Study investigating the feasibility and initial safety of the application of the haemostatic sponge ACF-Matrix haemostat in 10 Coronary Artery Bypass Grafting patients.
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Scientific title:
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TripleFive Pilot Study investigating the feasibility and initial safety of the (L)IMA bed application of ACF-Matrix haemostat in 10 CABG patients. - TripleFive Pilot |
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Date of first enrolment:
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1/3/2009 |
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Target sample size:
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10 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1670 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.M.
Bijlstra |
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Address:
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, Gelita Medical BV
Osdorperweg 590
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20-6675330 |
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Email:
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info@gelitamedical.com/bijlstra@tiscali.nl |
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Affiliation:
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Name:
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A.M.
Bijlstra |
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Address:
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, Gelita Medical BV
Osdorperweg 590
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20-6675330 |
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Email:
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info@gelitamedical.com/bijlstra@tiscali.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients 18 years or older;
2. Patients demonstrating signs and symptoms of coronary ischaemia and/or stenosis clinically considered suitable for correction by CABG surgery;
3. Investigator is satisfied that there are no other physical conditions present which would prevent the patient from entering and completing the Study;
4. Patients who are willing to participate in the proposed Study as evidenced by signing an informed consent form.
Exclusion criteria: 1. Patients coming in for an emergency CABG procedure;
2. Patients coming in for a re- CABG procedure;
3. Patients participating in another clinical trial;
4. Patients showing clinical signs of local or systemic infection, requiring (immediate intravenous) treatment with antibiotics;
5. Patients suffering from blood coagulation disorders;
6. Known presence of any disease or medical condition which may affect the wound healing process of the target wound (e.g. malignancy, vasculitis, connective tissue disease, immunological disorder);
7. A very poor life expectancy of less than 12 weeks, according to the investigator?s judgement;
8. Known allergy to porcine products;
9. Any physical or mental state that precludes ability to abide by Study criteria;
10. Patients not able to give consent, subsequent to initial informed consent;
11. The patient is pregnant or a nursing mother;
12. Evidence of chronic alcohol or drug abuse.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Coronary Artery Bypass Grafting (CABG), Coronary artery stenosis, Coronary ischaemia
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Intervention(s)
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Application of ACF-Matrix haemostat in the LIMA bed during CABG surgery.
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Primary Outcome(s)
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No unexpected post operative events in blood chemistry and no clinical signs and symptoms of tamponade.
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Secondary Outcome(s)
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Reduced post operative blood and fluid loss produced by the drains.
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Secondary ID(s)
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Gelita Medical
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Source(s) of Monetary Support
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Gelita Medical
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