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Nadroparine tijdens nachtelijke hemodialyse


- candidate number15452
- NTR NumberNTR4183
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2013
- Secondary IDsRTPO 900 Regionale toetsingscommissie patientgebonden onderzoek (RTPO), Medisch Centrum Leeuwarden
- Public TitleNadroparine tijdens nachtelijke hemodialyse
- Scientific TitleNadroparine tijdens de nacht
- ACRONYMN/A
- hypothesisNadroparine accumulates at higher dosage regimes in patient ondergoing nocturnal hemodialysis
- Healt Condition(s) or Problem(s) studiedHemodialysis, LMWH (low molecular weight heparin)
- Inclusion criteriaPatients (18
- Exclusion criteria- The use of other drugs wich block factor-Xa other than nadroparine. This includes dabigatran, apixaban, rivaroxaban, LMWH’s, heparine and fondaparinux.
- The use of Cofact or Beriplex during measurements
- Alteration in the dosage regime of anticoagulantia
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2013
- planned closingdate1-mrt-2014
- Target number of participants14
- InterventionsThe use of 4 bloodsamples taken from the dialysisline to determine anti-Xa activity (IU/ml)
- Primary outcomeAnti-Xa activity (IU/ml) before and after the first and last dialysis of the week to determine if accumulation occurs.
- Secondary outcome-Bloodflow during dialysis
-Flow of dialysis fluids
-Renal function
-Kt-V
-Bleeding events
-Clotting in the dialysis filter
- TimepointsBlood is taken 4 times. Before and after the first hemodialysis of the week and before and after the last hemodialysis of the week.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.H. Hemmelder
- CONTACT for SCIENTIFIC QUERIESDr. M.H. Hemmelder
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Leeuwarden
- PublicationsN/A
- Brief summaryPatients undergoing nocturnal hemodialysis are being administered an extra dosage of nadroparine compared to conventional hemodialysis. Nadroparine prevents clotting in the extra corporeal system. The currently used dosage regime is based on experience and international guidelines. There is no scientific evidence for this regime. It is unknown if nadroparine accumulates using a dosage of nadroparine wich is twice as high in a week compared to conventional hemodialysis. In theorie this could lead to a higher bleeding risk. This studie is designed to establish if and when accumulation occurs and to establish if the anti-Xa concentration measured are associated with a higher risk of bleeding events.
- Main changes (audit trail)
- RECORD24-sep-2013 - 14-okt-2013


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