Spinal Cord Injuries Clinical Trial
Official title:
Prospective, Non-randomized, Open-label, Mono-centric, Cohort Study on the Absorption of Oral Rivaroxaban in Patients With a Cervical Spinal Cord Injury
The primary objective of this study is to investigate the pharmacokinetic and -dynamic
properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)
individuals.
The secondary objective of this study is to determine the steady-state rivaroxaban activity
in cervical SCI individuals under long-term therapy.
Primary Objective In-house patients will be informed concerning the study and informed
consent will be collected.
During the screening day, in- / exclusion criteria will be assessed and a blood samples will
be taken for assessing haematology, clinical chemistry and coagulation parameters.
Furthermore, the evaluation day will be scheduled.
On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will
be introduced into a forearm or lower leg of each participant for the collection of blood at
the specified time points. Skin inspection for subcutaneous bleeding will be performed and
vital signs will be recorded. A blood sample will be taken for assessing haematology,
clinical chemistry and coagulation parameters.
Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer
Schering Pharma, Berlin, Germany).
Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after
and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity
will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12,
24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring
prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed
30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.
Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during
their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be
assessed, and the patients will be informed concerning the study and informed consent will be
collected.
Blood samples will be taken for assessing haematology, clinical chemistry and coagulation
parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs
will be performed.
A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and
secondary outcome parameters.
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