No registrations found.
ID
Source
Brief title
Health condition
accumulation of Nadroparine during hemodialysis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anti-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
Background summary
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.
Study objective
Nadroparine accumulates at higher dosage regimes in patient ondergoing nocturnal hemodialysis
Study design
Blood is taken 4 times. Before and after the first hemodialysis of the week and before and after the last hemodialysis of the week.
Intervention
The use of 4 bloodsamples taken from the dialysisline to determine anti-Xa activity (IU/ml)
Inclusion criteria
Patients (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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4011 |
| NTR-old | NTR4183 |
| Other | Regionale toetsingscommissie patientgebonden onderzoek (RTPO), Medisch Centrum Leeuwarden : RTPO 900 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |