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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.


- candidate number5304
- NTR NumberNTR1670
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2009
- Secondary IDsGelita Medical 
- Public TitleTripleFive 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.
- Scientific TitleTripleFive Pilot Study investigating the feasibility and initial safety of the (L)IMA bed application of ACF-Matrix haemostat in 10 CABG patients.
- ACRONYMTripleFive Pilot
- hypothesisThe application of the haemostatic device, ACF-matrix haemostat will reduce blood and fluid loss from the LIMA bed after CABG surgery.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Coronary artery stenosis, Coronary ischaemia
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate30-apr-2009
- Target number of participants10
- InterventionsApplication of ACF-Matrix haemostat in the LIMA bed during CABG surgery.
- Primary outcomeNo unexpected post operative events in blood chemistry and no clinical signs and symptoms of tamponade.
- Secondary outcomeReduced post operative blood and fluid loss produced by the drains.
- Timepoints1. Blood chemistry: < 24 h post-op;
2. Tamponade: < 4 weeks post-op.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.M. Bijlstra
- CONTACT for SCIENTIFIC QUERIES A.M. Bijlstra
- Sponsor/Initiator Gelita Medical
- Funding
(Source(s) of Monetary or Material Support)
Gelita Medical
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-feb-2009 - 14-sep-2009


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