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Sponsored by: |
Red Cross Hospital Beverwijk |
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Information provided by: | Red Cross Hospital Beverwijk |
ClinicalTrials.gov Identifier: | NCT00881088 |
Objective:
The purpose of this study is to determine the need for thromboprophylaxis in patients with a fracture of the lower extremity being treated conservatively in a below-knee plaster cast and to assess if both of the two tested prophylactic treatments are effective for this indication.
Hypothesis:
Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster cast.
Condition | Intervention | Phase |
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Deep Vein Thrombosis Pulmonary Embolism |
Drug: Nadroparin Drug: Fondaparinux |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast |
Estimated Enrollment: | 669 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Patients randomized to the no intervention group
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Nadroparin: Experimental
Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization
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Drug: Nadroparin
nadroparin 0,3 cc once daily during immobilization period
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Fondaparinux: Experimental
Subjects randomized to fondaparinux 2,5 mg daily group during immobilization
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Drug: Fondaparinux
Fondaparinux 2,5 mg daily during immobilization period
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Study Design:
A prospective, randomised, controlled, single blinded, multi-centre trial.
Intervention:
After meeting the inclusion criteria stated above and obtaining informed consent, patients will be randomly assigned to three groups: one receiving Nadroparine (2850 IE anti-Xa = 0,3 ml, given once daily), one receiving Fondaparinux (2,5 mg = 0,5 ml, given once daily) and one receiving no prophylaxis. These dosages are standard for the use in thromboprophylaxis. The first two groups will be instructed by a trained nurse in subcutaneous self-injection of the medicine and will be given pre-filled disposable syringes for once-daily administration for the duration of immobilisation. In the light of current scientific knowledge a placebo effect of subcutaneous injections of saline in the control group is implausible since the outcome measure (colour duplex sonography) is an objective one.
Patients further will receive a letter explaining the symptoms suggesting the development of deep-vein thrombosis, pulmonary embolism and adverse events and will be asked to contact the emergency room when any of these would occur.
All patient-information will be coded so that it cannot be traced back to the individual patient. This coded information can be used for publication.
Outcome:
At the time of removal of the plaster cast symptoms or signs suggestive of DVT will be noted and a colour duplex ultrasonography of the treated limb will be performed in all patients by an experienced technician according to a strict diagnostic test protocol (see enclosure 1). When there is incompressibility of a vein or lack of flow the diagnosis of DVT is made. The technician will be blinded to treatment. In case of a suspected pulmonary embolism pulmonary angiography will be performed.
The following risk-factors for DVT will be recorded: age, sex, body mass index (BMI), current smoking, use of estrogen-containing hormonal replacement therapy or oral contraception, active cancer (treatment on going or stopped for less than one year), congenital or acquired hypercoagulable state, previous deep venous thromboembolism and varicose veins.
Safety will be assessed as a secondary outcome. Adverse events such as haematomas, bleeding and allergic reactions will be recorded.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert J Derksen, MD, PhD | +31 6 24748122 | rjderksen@hotmail.com |
Contact: Roelf S Breederveld, MD, PhD | +31 251 264920 | breed@kpnplanet.nl |
Netherlands, N-Holland | |
Red Cross Hospital | Recruiting |
Beverwijk, N-Holland, Netherlands, 1942 LE | |
Contact: Robert J Derksen, MD, PhD +31 6 24748122 rjderksen@hotmail.com | |
Contact: Roelf S Breederveld, MD, PhD +31251264920 | |
Netherlands, North Holland | |
Medical Center Alkmaar | Not yet recruiting |
Alkmaar, North Holland, Netherlands, 1815 JD | |
Contact: J H van der Brand, MD, PhD | |
Spaarne Hospital | Not yet recruiting |
Hoofddorp, North Holland, Netherlands, 2134 TM | |
Contact: Taco S Bijlsma, MD, PhD | |
Slotervaart Hospital | Not yet recruiting |
Amsterdam, North Holland, Netherlands, 1006 BK | |
Contact: Boudewijn J Dwars, MD, PhD |
Study Director: | Roelf S Breederveld, MD, PhD | Red Cross Hospital Beverwijk |
Principal Investigator: | Yannick M Groutars, MD | Red Cross Hospital Beverwijk |
Responsible Party: | Red Cross Hospital, Beverwijk, the Netherlands ( R.J. Derksen, MD, PhD ) |
Study ID Numbers: | PROTECT |
Study First Received: | April 13, 2009 |
Last Updated: | May 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00881088 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Deep vein trombosis Profylaxis Below knee plaster cast Ankle fracture |
Anticoagulants Nadroparin Pulmonary Embolism Fractures, Bone Vascular Diseases Fibrinolytic Agents Fondaparinux Cardiovascular Agents Venous Thromboembolism |
Thrombosis Thromboembolism Org 31540 Fibrin Modulating Agents Embolism and Thrombosis Respiratory Tract Diseases Embolism Lung Diseases Venous Thrombosis |
Pulmonary Embolism Nadroparin Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Fondaparinux Cardiovascular Agents Pharmacologic Actions |
Thrombosis Org 31540 Fibrin Modulating Agents Embolism and Thrombosis Respiratory Tract Diseases Embolism Therapeutic Uses Lung Diseases Venous Thrombosis Cardiovascular Diseases |