Status:
UNKNOWN
Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures
Lead Sponsor:
Red Cross Hospital Beverwijk
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
Study Design: A prospective, randomised, controlled, single blinded, multi-centre trial. Intervention: After meeting the inclusion criteria stated above and obtaining informed consent, patients wil...
Eligibility Criteria
Inclusion
- at least 18 years
- with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
Exclusion
- Delay between injury and Emergency Department visit greater than three days
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
669 Patients enrolled
Trial Details
Trial ID
NCT00881088
Start Date
April 1 2009
End Date
April 1 2013
Last Update
December 18 2012
Active Locations (5)
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1
University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands
2
Medical Center Alkmaar
Alkmaar, North Holland, Netherlands, 1815 JD
3
VU University Medical Center
Amsterdam, North Holland, Netherlands, 1117 MB
4
Red Cross Hospital
Beverwijk, North Holland, Netherlands, 1942 LE