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Bloedverlies studie na een Aortaklep vervanging/


- candidate number12149
- NTR NumberNTR3378
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2012
- Secondary IDsP12-06 METC MST
- Public TitleBloedverlies studie na een Aortaklep vervanging/
- Scientific TitleBloodloss study after Aortic Valve Replacement.
- ACRONYM
- hypothesisThere is less bloodloss after an AVR with MECC perfusion.
- Healt Condition(s) or Problem(s) studiedBlood loss, Aortic Valve Replacement
- Inclusion criteria1. Above 18 years;
2. Only AVR operation;
3. No Re-Do operation.
- Exclusion criteria1. Under 18 years;
2. Double operation;
3. Re-do operation;
4. No informed consent given.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2012
- planned closingdate1-apr-2014
- Target number of participants310
- InterventionsAVR operation with ECC.
The aim of this study is to measure if there is a significant difference in bloodloss with two different heartlung machine's, comparing a MECCs ystem with a conventional ECC circuit, during an elective AortaValve replacement operation.
- Primary outcomePost-operative bloodloss 12 hours after arriving on the ICU. This is an objective measurement with the thoracic drainsysytem.
- Secondary outcome1. Numbers of bloodtransfusions;
2. Renal function 24 hours after surgery;
3. Duration of post-operative intubation;
4. Re-Sternotomy;
5. Cardiac markers after 24 hours.
- TimepointsDuring their stay on the ICU.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES K. Knol
- CONTACT for SCIENTIFIC QUERIESDr. G. Mecozzi
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summarySummary:
In the Netherlands about 15,000 heart operations annually take place. An increasing number of these patients are people who need an aortic valve replacement. This operation is in need of a heart-lung machine ECC. Heart surgery is associated with bloodloss. The use of Heparin, and the use of the heart lung machine can not be avoided that there is always any blood loss. However, blood loss and blood transfusion is associated with mortality and morbidity. Since a few years ther is a possibility for the use of a MECC system, (Minimum Extra Corporal Circulation). With this system there is less haemodilution, and contact with tubing of the heart-lung machine. Also the dosage of Heparin can be reduced. The hypothesis is that with this system can be reduced the chances of perioperatief blood loss.
- Main changes (audit trail)
- RECORD27-mrt-2012 - 13-apr-2012


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