Prevention of thrombosis in patients who are treated with a plaster cast for a fracture of the ankle or foot.

PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH A NONSURGICAL FRACTURE OF THE LOWER EXTREMITY IMMOBILISED IN A BELOW-KNEE PLASTER CAST.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22436

Enrollment

669

Registered

2009-03-23

Start date

2009-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis, plaster cast, fracture, lower extremity. Trombose, onderbeensgips, fractuur.

Interventions

1. 1 group no intervention (control group)

2. 1 group receiving Nadroparine (2850 IE anti-Xa = 0,3 ml, given once daily)

3. 1 group receiving Fondaparinux (2,5 mg = 0,5 ml, given once daily).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age ¡Ý 18 years; 2. # lower extremity; 3. Immobilisation in a below-knee plaster cast for a minimum of 4 weeks.

Exclusion criteria

Exclusion criteria: 1. Delay between injury and Emergency Department visit greater than three days; 2. Pregnancy/ lactation; 3. Body weight < 50 kg; 4. History of venous thromboembolism; 5. Hypercoagubility; 6. Severe hepatic impairment; 7. Severe renal impairment; 8. Known hypersensitivity to nadroparine or fondaparinux; 9. Documented congenital or acquired bleeding tendency/disorder; 10. Active, clinically significant bleeding; 11. Clinically significant bleeding within the past six months; 12. Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis; 13. Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg); 14. Haemorrhagic stroke within the previous two months; 15. Severe head injury within the previous three months; 16. Intraocular, spinal, and/or brain surgery within the previous twelve months; 17. Major surgery within the previous two months; 18. Treatment with LMWH or other anticoagulants; 19. Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis).

Design outcomes

Primary

Measure	Time frame
Venous thromboembolism (DVT or PE), assessed by colour duplex ultrasonography or pulmonary angiography.	—

Secondary

Measure	Time frame
Adverse associated with the use of nadroparine or fondaparinux.	—

Contacts

Public ContactY. Groutars

ygroutars@rkz.nl+31 (0)251 265464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)