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Tinzaparin in pediatric intensive care patients


- candidate number25485
- NTR NumberNTR6108
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-okt-2016
- Secondary IDsG16-082  METC Leids Universitair Medisch Centrum, Leiden
- Public TitleTinzaparin in pediatric intensive care patients
- Scientific TitleDosing and therapeutic drug monitoring of tinzaparin on the pediatric intensive care unit
- ACRONYM
- hypothesisMeasuring anti-Xa levels 4 hours after the first tinzaparin gift leads to faster achieving of adequate anti-Xa levels with fewer dose adjustments
- Healt Condition(s) or Problem(s) studiedAnticoagulation, Tinzaparin, Anti-Xa level
- Inclusion criteriaPatients on the pediatric intensive care unit with tinzaparin as therapeutic anticoagulation
- Exclusion criteria- Patients with tinzaparin as profylactic anticoagulation
- Patients with an coagulation disorder
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 12-sep-2016
- planned closingdate1-apr-2017
- Target number of participants50
- InterventionsNo specific interventions.
Observational studie.
- Primary outcome- Anti-Xa levels
- Time till adequate anti-Xa levels
- Doses that lead to adequate anti-Xa levels
- Secondary outcome- Influence of renal function
- Influence of hepatic function
- Comedication
- Presence of edema
- Disease severity (PRISM score)
- TimepointsStart: day of first tinzaparin gift. Further time points: days of anti-Xa levels
- Trial web siten.a.
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. P.P. Roeleveld
- CONTACT for SCIENTIFIC QUERIESDrs. P.P. Roeleveld
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of paediatric Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Pediatric Intensive Care
- PublicationsRoeleveld P.P. et al; Higher Tinzaparin Dosing Is Needed to Achieve Target Anti-Xa Levels in Pediatric Cardiac Intensive Care Patients. Pediatric Critical Care Medicine, January 2016.
- Brief summaryThis study evaluates if the policy change in 2014 is adequately pursued; are anti-Xa levels measured 4 hours after the first tinzaparin gift? It also investigates if with the new policy adequate anti-Xa levels are reached faster and with fewer dose adjustments.
- Main changes (audit trail)
- RECORD31-okt-2016 - 27-nov-2016


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