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Clinical Trials/NL-OMON39940
NL-OMON39940
Not yet recruiting
Phase 4

Prophylaxis of venous thromboembolism in patients with a fracture of the lower extremity being treated conservatively with a below-knee plaster cast. - PROTECT

Vrije Universiteit Medisch Centrum0 sites670 target enrollmentTBD
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Conditionspulmonary embolismthrombosis10014523

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
pulmonary embolism
Sponsor
Vrije Universiteit Medisch Centrum
Enrollment
670
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •The study groups and the control group will consist of patients of 18 years or older with a nonsurgical fracture of the lower extremity requiring immobilisation in a below\-knee plaster cast for a minimum of 4 weeks.

Exclusion Criteria

  • •Delay between injury and randomisation greater than three days
  • •Pregnancy/lactation
  • •Severe hepatic impairment
  • •Known hypersensitivity to fraxiparine or fondaparinux
  • •History of venous thromboembolism
  • •Documented congenital or acquired bleeding tendency/disorder(s)
  • •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)
  • •Haemorrhagic stroke within the previous two months
  • •Intraocular, spinal, and/or brain surgery within the previous twelve months

Outcomes

Primary Outcomes

Not specified

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