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Perioperative changes in the microvascular perfused boundry region in patients undergoing coronary artery bypass grafting


- candidate number15604
- NTR NumberNTR4222
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2013
- Secondary IDsNL45828.029.13 
- Public TitlePerioperative changes in the microvascular perfused boundry region in patients undergoing coronary artery bypass grafting
- Scientific TitleThe influence of different biocompatible-Perioperative changes in the microvascular perfused boundry region in patients undergoing coronary artery bypass grafting
- ACRONYMGlyCar
- hypothesisWe assume that the increase of perfused boundry region will be more pronounced with the use of a phosphorylcholine-coated extracorporal circuit then with the use of a heparin-coated extracorporeal circuit.
- Healt Condition(s) or Problem(s) studiedMicrocirculation, Glycocalyx, Cardia Surgery, Heparin, Cardiovascular disease risk
- Inclusion criteriaadult patients (age 18-85 years) undergoing CABG surgery, informed consent
- Exclusion criteriaRe-operation, emergency operation, patients with diabetes mellitus type 1, patients with a history of hematologic or hepatic diseases or renal replacement therapy, patients with a Body Mass Index (BMI) over 35 kg/m2
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate30-aug-2015
- Target number of participants44
- Interventionsnone
- Primary outcomePerioperative changes in the perfused boundry region (PBR) of the sublingual microvasculature
- Secondary outcomePerioperative changes in plasma markers for shedding of the glycocalyx such as heparan sulfate, hyaluronic acid and syndecan-1
- TimepointsBlood will be drawn and several microcirculatory imaging parameters will be measured before surgery (T0), before (T1) and after administration of heparin (T2), after initiation of CPB (T3), after placement of the side clamp (T4), after administration of protamine (T5), after infusion of concentrated red blood cells (T6), 3 hours after the patient has arrived at the ICU (T7), and 24 hours (T8) and 72 hours (T9) following surgery
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.B.A. Vonk
- CONTACT for SCIENTIFIC QUERIESDrs. D. Veerhoek
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryThe endothelial glycocalyx (EGC) is a gel-like layer that acts as a natural coating for endothelial cells, thereby preventing these cells from having direct contact with circulating blood cells. In order to reduce the inflammatory and procoagulant response during cardiopulmonary bypass in patients undergoing cardiac surgery through contact activation, extracorporeal circuits are coated with a biocompatible surface. In VU University Medical Centre, cardiopulmonary bypass is mostly performed using a heparin-coated extracorporeal circuit in combination with full anticoagulation by heparin infusion. Alternatively, a phosphorylcholine-coated extracorporeal circuit is used, but it is unknown how these different biocompatible-coated extracorporeal circuits will contribute to the preservation of the glycocalyx during cardiac surgery.
- Main changes (audit trail)
- RECORD25-okt-2013 - 19-nov-2013


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