- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542762
Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation (Pot-Cast)
Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
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 exists. In the proposed study we will use relevant symptomatic endpoints in a large cohort of patients. Furthermore we will follow subjects with an adverse event for a longer period, during which we will assess the long term sequelae of these events. Lastly, we will determine high risk groups that will benefit most from anticoagulant treatment.
Objective:
Comparative effectiveness research to determine cost-effectiveness of an existing healthcare policy, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition we will investigate personalized prophylaxis based on genetic and acquired risk factors.
Study Design:
A randomized controlled trial comparing a policy with the anticoagulant LMWH to a policy with no anticoagulant in patients with lower leg cast immobilization.
Determination of genetic and acquired risk factors will be performed at the start of the study. Based on the presence or absence of these factors we will assign a risk profile to each patient
Study Population:
The study population will consist of 1500 patients in need for a plaster cast of the lower leg, e.g. after trauma or overuse injuries of ankle and foot. These patients will be recruited from 5 hospitals in the Leiden/Den Haag region over a two-year inclusion period. All patients over 18 years will be eligible, except patients with a contra-indication or an absolute indication for LMWH use
Intervention:
LMWH (for example nadroparin 2850 IE s.c. once daily, > 100kg 5700IE sc) for the duration of the immobilization (average 6-8 weeks) vs no treatment.
Each hospital will use a LMWH according to their own preference.
Blood taken at the emergency department will be analyzed on common single nucleotide polymorphisms (SNPs) known to strongly affect thrombotic risk; on levels of coagulation factors in plasma (of which high or low levels are known to increase the risk). Patients will also be screened on acquired risk factors for thrombosis through a questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
We will compare two standard treatment modes that are currently both used depending on the physician's or hospital's preference. The patients in our trial will be subjected to one of these standard treatments. It is therefore not expected that participation will lead to an increased health risk. LMWHs like Nadroparin and Dalteparin are no experimental pharmaceuticals; both have been registered in the Netherlands for these indications since 1989.
Not participating in the trial may, depending on the physician, still lead to treatment with an LMWH.
All patients will need to undergo one venepuncture for blood sampling for the study. This blood sample will be taken at the first day of immobilization. No extra hospital visits are required. Patients will be contacted by an electronic questionnaire 3 weeks and 7 weeks after the start of immobilization and by telephone after three months.
One questionnaire concerning risk factors for thrombosis, bleeding and patients demographics will be filled in at the first day of cast immobilization.
Only subjects with clinically relevant adverse events (and a similar random sample of subjects without a clinically relevant adverse event) will be monitored for a two year period after the event (in total expected to be about 30 subjects). After six months, one year and two years after the event, patients will be seen for clinical examination and quality of life assessment by means of a questionnaire.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Overijssel
-
Zwolle, Overijssel, Netherlands, 8000 GK
- De Isala Klinieken
-
-
Zuid Holland
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Den Haag, Zuid Holland, Netherlands, 2597 AX
- Bronovo Ziekenhuis
-
-
Zuid-Holland
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Delft, Zuid-Holland, Netherlands, 2625 AD
- Reinier de Graaf Gasthuis
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Den Haag, Zuid-Holland, Netherlands, 2512 VA
- Medisch Centrum Haaglanden
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Den Haag, Zuid-Holland, Netherlands, 2566 MJ
- HagaZiekenhuis
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Gouda, Zuid-Holland, Netherlands, 2803 HH
- Groene Hart Ziekenhuis
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Leiden, Zuid-Holland, Netherlands, 2333 ZA
- Leiden University Medical Center
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Leiderdorp, Zuid-Holland, Netherlands, 2353 GA
- Rijnland Ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LMWH
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).
Other Names:
|
NO_INTERVENTION: No intervention
750 patients with lower leg cast immobilization will be randomized tot receive no treatment with LMWH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic deep venous thrombosis (DVT)
Time Frame: 3 Months
|
Symptomatic deep venous thrombosis confirmed with compression ultrasonography
|
3 Months
|
Pulmonary Embolism (PE)
Time Frame: 3 months
|
Fatal or non-fatal pulmonary embolism confirmed with:
|
3 months
|
Major Bleeding
Time Frame: 3 months
|
Major bleeding, defined as:
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
3 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL35774.058.11
- 171102001 (OTHER_GRANT: ZonMw)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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