| - candidate number | 2475 |
| - NTR Number | NTR911 |
| - ISRCTN | ISRCTN72245261 |
| - Date ISRCTN created | 7-mrt-2007 |
| - date ISRCTN requested | 6-mrt-2007 |
| - Date Registered NTR | 19-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Prevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses. A randomised double-blind controlled trial in patients with haematological malignancies. |
| - Scientific Title | Prevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses. A randomised double-blind controlled trial in patients with haematological malignancies. |
| - ACRONYM | N/A |
| - hypothesis | Urokinase rinsed will lead to less CONS infections in patients with hematological malignancies and central vein catheters. |
| - Healt Condition(s) or Problem(s) studied | Central vein catheter , Hematological malignancy, Urokinase |
| - Inclusion criteria | 1. Age of 18 years or older; 2. Admission to undergo intensive cytotoxic treatment associated with disruption of the mucosa and deep granulocytopenia (PMNs < 0.1 x 109/L) for at least 14 days. |
| - Exclusion criteria | 1. Patients with pre-existing bleeding disorders; 2. Patients treated with intravenous unfractionated heparin to prevent veno-occlusive disease; 3. Patients with documented septicaemia prior to the start of the study. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jan-1996 |
| - planned closingdate | 1-feb-1999 |
| - Target number of participants | 161 |
| - Interventions | Urokinase rinses of central vein catheter three times weekly (25,000 IU, 5 ml of 5,000 IU/ml). |
| - Primary outcome | The main endpoints of the study were the occurrence of any CVC-related infection by CoNS. According to previously described criteria these infections were classified as local CVC related infection (insertion site infection or significant CVC colonization) and systemic CVC related infections. |
| - Secondary outcome | Secondary endpoints in this study were CVC-related infections caused by other microbial pathogens, premature CVC removal, secondary CVC-related complications (metastatic infection, CVC-related thrombosis), non-CVC related septicaemia bleeding and death. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MD. PhD. M.V. Huisman |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. M.V. Huisman |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC), Department of Hematology |
| - Funding (Source(s) of Monetary or Material Support) | Leiden University Medical Center (LUMC), Department of Hematology |
| - Publications | J Clin Oncol. 2008 Jan 20;26(3):428-33 |
| - Brief summary | To investigate whether three times weekly urokinase rinsing of central venous catheter (CVC) reduces the incidence or severity of CVC-related infections by coagulase-negative staphylococci (CoNS) in patients undergoing intensive cytotoxic treatment for haematological malignancies. |
| - Main changes (audit trail) | |
| - RECORD | 19-feb-2007 - 28-aug-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl