drugset / Trial / NCT01542723

Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy

NCT01542723

RandomizedParallel-groupOpen-labelPrevention

Summary

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. 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) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

Timeline

Start
2012-05
Primary completion
2016-07
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject LMWH Unknown
Subject Nadroparin Calcium Other / unclassified 2850 iu Subcutaneous
Subject Nadroparin Calcium Other / unclassified 5700 iu Subcutaneous