Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
Currently, guidelines and clinical practice differ considerably with respect to use of
anticoagulant treatment during cast immobilization of the lower leg. Trials that have been
carried out were aimed at efficacy only, had small sample sizes and therefore mainly used
asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could
not be established, hence the current controversy. In the proposed study the investigators
will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the
investigators will follow subjects with an adverse event for a longer period, during which
the investigators will assess the long term sequelae of these events. Lastly, the
investigators will determine high risk groups that will benefit most from anticoagulant
treatment.
Objective: Comparative effectiveness research to determine cost-effectiveness of two existing
policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster
cast immobilization following surgical or conservative treatment. In addition the
investigators will investigate personalized prophylaxis based on genetic and acquired risk
factors.
Phase:
N/A
Details
Lead Sponsor:
Suzanne C. Cannegieter, MD PhD
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development