Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation
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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 |
- 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.
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (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:
|
|
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 |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Suzanne C Cannegieter, PhD, MD | +31715261508 | s.c.cannegieter@lumc.nl |
| Contact: Rob GHH Nelissen, PhD, MD | +31715263606 | r.g.h.h.nelissen@lumc.nl |
| Netherlands | |
| De Isala Klinieken | Recruiting |
| Zwolle, Overijssel, Netherlands, 8000 GK | |
| Reinier de Graaf Gasthuis | Recruiting |
| Delft, Zuid-Holland, Netherlands, 2625 AD | |
| Medisch Centrum Haaglanden | Recruiting |
| Den Haag, Zuid-Holland, Netherlands, 2512 VA | |
| HagaZiekenhuis | Not yet recruiting |
| Den Haag, Zuid-Holland, Netherlands, 2566 MJ | |
| Groene Hart Ziekenhuis | Recruiting |
| Gouda, Zuid-Holland, Netherlands, 2803 HH | |
| Leiden University Medical Center | Recruiting |
| Leiden, Zuid-Holland, Netherlands, 2333 ZA | |
| Study Director: | Suzanne C Cannegieter, PhD, MD | Leiden University Medical Center |
| Principal Investigator: | Rob GHH Nelissen, PhD, MD | Leiden University Medical Center |
More Information
No publications provided
| 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: | February 13, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Leiden University Medical Center:
|
Deep venous thrombosis Pulmonary Embolism Lower leg Cast immobilization |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thromboembolism |
Heparin, Low-Molecular-Weight Nadroparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013