Nadroparine accumulates at higher dosage regimes in patient ondergoing nocturnal hemodialysis
ID
Bron
Verkorte titel
Aandoening
accumulation of Nadroparine during hemodialysis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Anti-Xa activity (IU/ml) before and after the first and last dialysis of the week to determine if accumulation occurs.
Achtergrond van het onderzoek
Patients 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.
Doel van het onderzoek
Nadroparine accumulates at higher dosage regimes in patient ondergoing nocturnal hemodialysis
Onderzoeksopzet
Blood is taken 4 times. Before and after the first hemodialysis of the week and before and after the last hemodialysis of the week.
Onderzoeksproduct en/of interventie
The use of 4 bloodsamples taken from the dialysisline to determine anti-Xa activity (IU/ml)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients (18
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4011 |
| NTR-old | NTR4183 |
| Ander register | Regionale toetsingscommissie patientgebonden onderzoek (RTPO), Medisch Centrum Leeuwarden : RTPO 900 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |