Clinically important venous thromboembolism following lower extremity fractures: epidemiology and preventio

Not Applicable

Completed

• Conditions: Isolated below-knee fractures (tibia and/or fibula) requiring surgical repair; Injury, Occupational Diseases, Poisoning; Fractures

• Registration Number: ISRCTN23254458
• Lead Sponsor: niversity of Toronto (Canada)

Brief Summary

1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25900749 (added 31/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-24
• Study Completion: 2007-03-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Age >16 years, either sex
2. Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
a. Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
b. Isolated fractures of the fibula including fibular head, fibular diaphysis, distal fibula and lateral malleolus
c. Combined fractures of the tibia and fibula
3. Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved
4. Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission

Exclusion Criteria

1. Patients presenting greater than 72 hours after injury
2. Major injury involving other site(s)
3. Lower extremity vascular injury requiring surgical repair
4. Known systemic bleeding disorder or international normalized ratio (INR) >1.5, aPTT >40 sec, or platelets <50 x 10^9/l at baseline
5. Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
6. Intracranial or other major bleed in the previous 4 weeks
7. Ongoing need for anticoagulation for other reasons
8. Previous DVT or PE (objectively proven or treated with anticoagulants)
9. Known molecular hypercoagulable state
10. Active cancer
11. Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine >300 µmol/l)
12. Hypersensitivity to heparin or LMWH (including history of HIT)
13. Inability to arrange out-of-hospital study medication administration
14. Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 + 2, 6 weeks, 3 months)
15. Inability or refusal to provide informed consent
16. Previous participation in this study
17. Estimated weight less than 40 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically important venous thromboembolism at 3 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinically important VTE during the prophylaxis phase (day 0-14 + 2)<br> 2. Symptomatic VTE (either symptomatic deep vein thrombosis [DVT] or pulmonary embolism [PE] or fatal PE) during the post-prophylaxis phase (day 14 + 2 to 3 months + 1 week)<br> 3. Bleeding<br> 4. Cost-effectiveness<br>