The application of the haemostatic device, ACF-matrix haemostat will reduce blood and fluid loss from the LIMA bed after CABG surgery.
ID
Bron
Verkorte titel
Aandoening
CABG surgery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
No unexpected post operative events in blood chemistry and no clinical signs and symptoms of tamponade.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
The application of the haemostatic device, ACF-matrix haemostat will reduce blood and fluid loss from the LIMA bed after CABG surgery.
Onderzoeksopzet
1. Blood chemistry: < 24 h post-op;
2. Tamponade: < 4 weeks post-op.
Onderzoeksproduct en/of interventie
Application of ACF-Matrix haemostat in the LIMA bed during CABG surgery.
Publiek
Gelita Medical BV
Osdorperweg 590
Amsterdam
The Netherlands
+31 (0)20-6675330
info@gelitamedical.com/bijlstra@tiscali.nl
Wetenschappelijk
Gelita Medical BV
Osdorperweg 590
Amsterdam
The Netherlands
+31 (0)20-6675330
info@gelitamedical.com/bijlstra@tiscali.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL1590 |
NTR-old | NTR1670 |
Ander register | : Gelita Medical |
ISRCTN | ISRCTN wordt niet meer aangevraagd |