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Prophylaxis of Thromboembolic Complications Trial: Thromboprophylaxis Needed in Below Knee Plaster Cast Immobilization for Ankle and Foot Fractures

NCT00881088 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2012-12-18

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Nadroparin

nadroparin 0,3 cc once daily during immobilization period

DRUG

Fondaparinux

Fondaparinux 2,5 mg daily during immobilization period

Sponsors & Collaborators

  • Red Cross Hospital Beverwijk

    lead OTHER

Principal Investigators

  • Roelf S Breederveld, MD, PhD · Red Cross Hospital Beverwijk

  • Yannick M Groutars, MD · Red Cross Hospital Beverwijk

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881088 on ClinicalTrials.gov