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Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation (Pot-Cast)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Suzanne C. Cannegieter, MD PhD, Leiden University
ClinicalTrials.gov Identifier:
NCT01542762
First received: February 27, 2012
Last updated: May 31, 2016
Last verified: May 2016
  Purpose

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 Intervention
Deep Venous Thrombosis
Pulmonary Embolism
Drug: LMWH

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1500
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542762

Locations
Netherlands
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
HagaZiekenhuis
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
Investigators
Study Director: Suzanne C Cannegieter, PhD, MD Leiden University Medical Center
Principal Investigator: Rob GHH Nelissen, PhD, MD Leiden University Medical Center
  More Information

Responsible Party: Suzanne C. Cannegieter, MD PhD, Study director, Leiden University
ClinicalTrials.gov Identifier: NCT01542762     History of Changes
Other Study ID Numbers: NL35774.058.11  171102001 
Study First Received: February 27, 2012
Last Updated: May 31, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Leiden University Medical Center:
Deep venous thrombosis
Pulmonary Embolism
Lower leg Cast immobilization

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Nadroparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016