Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation (Pot-Cast)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01542762|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Deep Venous Thrombosis Pulmonary Embolism||Drug: LMWH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
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.
- Symptomatic deep venous thrombosis (DVT) [ Time Frame: 3 Months ]Symptomatic deep venous thrombosis confirmed with compression ultrasonography
- Pulmonary Embolism (PE) [ Time Frame: 3 months ]
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 ]
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 ]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 ]Superficial incisional surgical site infection, deep incisional surgical site infection of organ/space surgical site infection according to the definitions of the CDC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542762
|De Isala Klinieken|
|Zwolle, Overijssel, Netherlands, 8000 GK|
|Den Haag, Zuid Holland, Netherlands, 2597 AX|
|Reinier de Graaf Gasthuis|
|Delft, Zuid-Holland, Netherlands, 2625 AD|
|Medisch Centrum Haaglanden|
|Den Haag, Zuid-Holland, Netherlands, 2512 VA|
|Den Haag, Zuid-Holland, Netherlands, 2566 MJ|
|Groene Hart Ziekenhuis|
|Gouda, Zuid-Holland, Netherlands, 2803 HH|
|Leiden University Medical Center|
|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|