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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. Identifier: NCT01542762
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : October 11, 2016
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Suzanne C. Cannegieter, MD PhD, Leiden University

Brief 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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Pulmonary Embolism Drug: LMWH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LMWH
750 patients with lower leg cast immobilization will be randomized tot receive treatment with a LMWH.
Drug: 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).

Other Names:
  • Nadroparine
  • Dalteparine

No Intervention: No intervention
750 patients with lower leg cast immobilization will be randomized tot receive no treatment with LMWH.

Primary Outcome Measures :
  1. Symptomatic deep venous thrombosis (DVT) [ Time Frame: 3 Months ]
    Symptomatic deep venous thrombosis confirmed with compression ultrasonography

  2. 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

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications:

  • Trauma of the lower leg
  • Surgery of the lower leg followed by lower leg immobilization with a plaster cast
  • Non-traumatic indications

Exclusion Criteria:

  • Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)
  • Pregnancy
  • Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.
  • History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)
  • Mental of physical disability to fulfill study requirements
  • Insufficient knowledge of the Dutch language
  • Previous participation in the Pot-(K)Cast study

Information from the National Library of Medicine

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 identifier (NCT number): NCT01542762

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De Isala Klinieken
Zwolle, Overijssel, Netherlands, 8000 GK
Bronovo Ziekenhuis
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
Rijnland Ziekenhuis
Leiderdorp, Zuid-Holland, Netherlands, 2353 GA
Sponsors and Collaborators
Suzanne C. Cannegieter, MD PhD
ZonMw: The Netherlands Organisation for Health Research and Development
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Study Director: Suzanne C Cannegieter, PhD, MD Leiden University Medical Center
Principal Investigator: Rob GHH Nelissen, PhD, MD Leiden University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Suzanne C. Cannegieter, MD PhD, Study director, Leiden University Identifier: NCT01542762    
Other Study ID Numbers: NL35774.058.11
171102001 ( Other Grant/Funding Number: ZonMw )
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Suzanne C. Cannegieter, MD PhD, Leiden University:
Deep venous thrombosis
Pulmonary Embolism
Lower leg Cast immobilization
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action