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| ID | Type | Description | Link |
|---|---|---|---|
| NTR668 | Registry Identifier | Nederlands Trial Register | |
| 12617 | Other Grant/Funding Number | Dutch Cancer Society |
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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
| UMC Utrecht | OTHER |
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The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) | Experimental |
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| Heparin lock (heparin 100 IU/mL) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) | Device | The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of central line associated bloodstream infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first central line associated bloodstream infection | From central venous access device insertion until the end of follow-up (maximum of 90 days). | |
| Central line associated bloodstream infection incidence per 1,000 central venous access device-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ceder H van den Bosch, MSc | Contact | +31625395632 | c.h.vandenbosch-4@prinsesmaximacentrum.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Máxima Center for Pediatric Oncology | Recruiting | Utrecht | 3511XK | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36944461 | Derived | van den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760. |
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The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.
Before the end of the study the study protocol, statistical analysis plan and informed consent forms will be published in a peer-reviewed journal. The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.
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| Heparin lock (heparin 100 IU/mL) | Device | The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle. |
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| From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of symptomatic central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of bacteraemia | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of local infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Incidence of and reasons for central venous access device-removal | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Cultured microorganisms causing central line associated bloodstream infections | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis | From central venous access device insertion until the end of follow-up (maximum of 90 days). |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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