| - candidate number | 2473 |
| - NTR Number | NTR909 |
| - ISRCTN | ISRCTN35472475 |
| - Date ISRCTN created | 7-mrt-2007 |
| - date ISRCTN requested | 6-mrt-2007 |
| - Date Registered NTR | 16-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | The marker study |
| - Scientific Title | Markers of endothelial activation and damage in haematological patients in relation to efficacy of transfusion support: a pilot study. |
| - ACRONYM | the marker study |
| - hypothesis | Efficacy of transfusion support depends on disease and treatment related patient factors. Markers of endothelial damage have been identified, but till today not in relation to the efficacy of transfusions. |
| - Healt Condition(s) or Problem(s) studied | Hemato-oncological patients, Sickle cell disease, Hematological patients |
| - Inclusion criteria | 1. Age > 18 years; 2. Hemato-oncological disease; 3. Sickle cell disease; 4. Informed consent |
| - Exclusion criteria | 1. Active cardiovascular disease; 2. Recent thrombo-embolism. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-apr-2008 |
| - Target number of participants | 40 |
| - Interventions | None |
| - Primary outcome | Efficacy of platelet transfusion or red blood cell exchange transfusion in hemato-oncological patients and sickle cell patients, respectively, in relation to several endothelial activation markers. |
| - Secondary outcome | n.a. |
| - Timepoints | |
| - Trial web site | none |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | M.D. J.L.H. Kerkhoffs |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. A. Brand |
| - Sponsor/Initiator | Sanquin Blood Bank South West Region |
| - Funding (Source(s) of Monetary or Material Support) | Sanquin Southwest |
| - Publications | N/A |
| - Brief summary | 20 patients with a hemato-oncological diagnosis and 20 patients with sickle cell disease will be asked to participate. After informed consent two blood samples will be drawn, before and after intervention (platelet transfusion and red blood cell exchange respectively). These samples will be used to test several known markers of endothelial cell activation/damage in a pilot study. |
| - Main changes (audit trail) | |
| - RECORD | 16-feb-2007 - 7-mrt-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl