drugset / Trial / NCT00881088

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

NCT00881088

Phase 2/3 Unknown 669 enrolled Red Cross Hospital Beverwijk
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2009-04
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 2.5 mg Subcutaneous
Subject Nadroparin Calcium Other / unclassified 2850 iu Subcutaneous