Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures
NCT ID: NCT00881088
Last Updated: 2012-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
669 participants
INTERVENTIONAL
2009-04-30
2013-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
Patients randomized to the no intervention group
No interventions assigned to this group
Nadroparin
Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization
Nadroparin
nadroparin 0,3 cc once daily during immobilization period
Fondaparinux
Subjects randomized to fondaparinux 2,5 mg daily group during immobilization
Fondaparinux
Fondaparinux 2,5 mg daily during immobilization period
Interventions
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Nadroparin
nadroparin 0,3 cc once daily during immobilization period
Fondaparinux
Fondaparinux 2,5 mg daily during immobilization period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
Exclusion Criteria
* Pregnancy/ lactation
* Body weight \< 50 kg
* Severe hepatic impairment
* Severe renal impairment (creatinin-clearance \< 30 ml/min)
* Known hypersensitivity to nadroparine or fondaparinux
* Pre-existing venous thromboembolism
* Pre-existing post-thrombotic syndrome
* Documented congenital or acquired bleeding tendency/disorder(s)
* Active, clinically significant bleeding
* Clinically significant bleeding within the past six months
* Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis
* Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
* Bacterial endocarditis
* Haemorrhagic stroke within the previous two months
* Severe head injury within the previous three months
* Intraocular, spinal, and/or brain surgery within the previous twelve months
* Major surgery within the previous two months
* Treatment with LMWH or other anticoagulants
* Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis)
18 Years
ALL
No
Sponsors
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Red Cross Hospital Beverwijk
OTHER
Responsible Party
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R.J. Derksen
Principal investigator
Principal Investigators
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Roelf S Breederveld, MD, PhD
Role: STUDY_DIRECTOR
Red Cross Hospital Beverwijk
Yannick M Groutars, MD
Role: PRINCIPAL_INVESTIGATOR
Red Cross Hospital Beverwijk
Locations
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University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands
Medical Center Alkmaar
Alkmaar, North Holland, Netherlands
VU University Medical Center
Amsterdam, North Holland, Netherlands
Red Cross Hospital
Beverwijk, North Holland, Netherlands
Spaarne Hospital
Hoofddorp, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jan Paul Frolke, MD, PhD
Role: primary
J H van der Brand, MD, PhD
Role: primary
Fred C Bakker, MD, PhD
Role: primary
Jels Fongers, MD
Role: backup
Robert J Derksen, MD, PhD
Role: primary
Roelf S Breederveld, MD, PhD
Role: backup
Nico Sosef, MD
Role: primary
References
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Bruntink MM, Groutars YME, Schipper IB, Breederveld RS, Tuinebreijer WE, Derksen RJ; PROTECT studygroup. Nadroparin or fondaparinux versus no thromboprophylaxis in patients immobilised in a below-knee plaster cast (PROTECT): A randomised controlled trial. Injury. 2017 Apr;48(4):936-940. doi: 10.1016/j.injury.2017.02.018. Epub 2017 Feb 22.
Other Identifiers
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PROTECT
Identifier Type: -
Identifier Source: org_study_id