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

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Red Cross Hospital Beverwijk
• Treatments: Fondaparinux; Nadroparin; PENTA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)