Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks|
- Symptomatic deep venous thrombosis (DVT) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Symptomatic deep venous thrombosis confirmed with compression ultrasonography
- Pulmonary Embolism (PE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Fatal or non-fatal pulmonary embolism confirmed with:
- an intraluminal filling defect in segmental or more proximal branches on spiral CT scan, or
- a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan, or
- detected at autopsy
- Major Bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Major bleeding, defined as:
- a fatal bleeding, or
- symptomatic bleeding in a critical area or organ, or
- extrasurgical site bleeding causing a fall in hemoglobin level of 1.24mmol/L (2.0g/dL) or more, leading to transfusion of one or more units of whole blood or red cells, or
- surgical site bleeding that requires a second intervention or a hemarthrosis interfering with rehabilitation, or surgical site bleeding that needs blood suppletion.
- Other clinically relevant bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Other clinically relevant bleeding, defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.
- Surgical site infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Superficial incisional surgical site infection, deep incisional surgical site infection of organ/space surgical site infection according to the definitions of the CDC.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
750 patients with lower leg cast immobilization will be randomized tot receive treatment with a LMWH.
Each hospital will use a LMWH according to their own preferences.
Prophylactic dosage of LMWH (for example nadroparin 2850 IE s.c.) once daily for the duration of the immobilization (average 6 weeks). If the patient's weight is more than 100kg a double dose of LMWH will be given (in case of Nadroparin 5700 IE s.c. once daily).
No Intervention: No intervention
750 patients with lower leg cast immobilization will be randomized tot receive no treatment with LMWH.
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|Contact: Suzanne C Cannegieter, PhD, MDfirstname.lastname@example.org|
|Contact: Rob GHH Nelissen, PhD, MDemail@example.com|
|De Isala Klinieken||Recruiting|
|Zwolle, Overijssel, Netherlands, 8000 GK|
|Reinier de Graaf Gasthuis||Recruiting|
|Delft, Zuid-Holland, Netherlands, 2625 AD|
|Den Haag, Zuid-Holland, Netherlands, 2566 MJ|
|Medisch Centrum Haaglanden||Recruiting|
|Den Haag, Zuid-Holland, Netherlands, 2512 VA|
|Groene Hart Ziekenhuis||Recruiting|
|Gouda, Zuid-Holland, Netherlands, 2803 HH|
|Leiden University Medical Center||Recruiting|
|Leiden, Zuid-Holland, Netherlands, 2333 ZA|
|Leiderdorp, Zuid-Holland, Netherlands, 2353 GA|
|Study Director:||Suzanne C Cannegieter, PhD, MD||Leiden University Medical Center|
|Principal Investigator:||Rob GHH Nelissen, PhD, MD||Leiden University Medical Center|