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Het effect van een bloedtransfusie bij kritiek zieke patiŽnten


- candidate number27587
- NTR NumberNTR6596
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jul-2017
- Secondary IDsNL61833.018.17 MEC AMC
- Public TitleHet effect van een bloedtransfusie bij kritiek zieke patiŽnten
- Scientific TitleThe effects of blood transfusion of red blood cells in the critically ill II
- ACRONYMTETRIS2
- hypothesis
- Healt Condition(s) or Problem(s) studiedIntensive care, Sepsis, Blood transfusions, Microcirculation
- Inclusion criteria- Patients must receive an erythrocyte transfusion on the ICU, to correct for anemia
- Patients may not have received a transfusion with red blood cells, plasma or thrombocytes in the previous 24 hours
- Patients may not receive more than 1 unit of RBCs
- Patients may not be suspected of having an active bleeding
- Exclusion criteria- Patients who have not given informed consent
- Patients who pose difficulties in securing blood products (e.g. rare blood groups)
- Patients who receive more than 1 unit of RBCs in 1 transfusion episode
- No arterial catheter in situ
- Patients who received biotinylated blood before (earlier enrollment in TETRIS2)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate1-aug-2019
- Target number of participants86
- InterventionsPatients will receive biotinylated blood to be able to distinguish the donors blood from the patients own blood
- Primary outcomePhosphatidylserine exposure on donor RBCs
- Secondary outcome- Clearance of erythrocytes
- Expression of clearance markers other than PS
- Markers of immune cell and endothelial cell activation and adhesion
- Complete blood count
- Levels of fibrinogen, APTT, PTT and D-dimers in blood (to calculate DIC score)
- Markers of inflammatory host respons
- Sublingual microcirculatory density and perfusion velocity, as visualized with SDF
- Tissue oxygenation, as measured with NIRS
- Time on mechanical ventilation
- Duration of ICU stay
- Duration of hospital stay
- 28 day mortality
- DNA staining on residual red blood cell material,
- Red blood cell deformability, activation status and cell-binding ability
- Oxygen tension in the mitochondria (MitoPO2)
- TimepointsBefore transfusion and 1, 24 hours and 48 hours after transfusion
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. N.P. Juffermans
- CONTACT for SCIENTIFIC QUERIESDr. N.P. Juffermans
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryInclusion are going to take place in the Academic medical centre, Amsterdam, the Netherlands
- Main changes (audit trail)
- RECORD26-jul-2017 - 12-aug-2017


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