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Comparison of Volulyte® versus Tetraspan® in patients undergoing cardiopulmonary bypass.


- candidate number10518
- NTR NumberNTR3137
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-nov-2011
- Secondary IDs2011/189 MEC UZ Brussel
- Public TitleComparison of Volulyte® versus Tetraspan® in patients undergoing cardiopulmonary bypass.
- Scientific TitleComparative study of two balanced hydroxyethyl starch solutions in patients undergoing cardiopulmonary bypass during valvular cardiac surgery.
- ACRONYMN/A
- hypothesisDoes the use of two different balanced hydroxyethyl starch solutions, influence the coagulation profile, acid-base status, ionogram, colloid oncotic pressure and organ function in patients undergoing cardiopulmonary bypass.
- Healt Condition(s) or Problem(s) studiedCardiac surgery, Cardiopulmonary bypass, Balanced hydroxyethyl starch
- Inclusion criteriaAdult patients undergoing valvular cardiac surgery with cardiopulmonary bypass.
- Exclusion criteriaPatients with preoperative renal failure, redo or urgent operations, IABP.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate31-mrt-2012
- Target number of participants60
- InterventionsAdministration of Tetraspan versus Volulyte in cardiopulmonary bypass priming and as resuscitation fluid during valvular cardiac surgery.
- Primary outcome1. Coagulation status;
2. Colloid osmotic pressure;
3. Acid/base balance and ion balance.
- Secondary outcome1. Blood loss;
2. Morbidity.
- TimepointsAfter induction of anesthesia, after 15 min. on cardiopulmonary bypass, after cardiopulmonary bypass, first postoperative day.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Luc Puis
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryThe study is designed to elucidate the differences in coagulation profile, acid-base status, ionogram, colloid oncotic pressure and organ function in patients undergoing cardiopulmonary bypass during cardiac valvular surgery.
- Main changes (audit trail)
- RECORD10-nov-2011 - 8-jun-2015


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