Clinically important venous thromboembolism following lower extremity fractures: epidemiology and prevention
| ISRCTN | ISRCTN23254458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23254458 |
| ClinicalTrials.gov (NCT) | NCT00187408 |
| Protocol serial number | DCT-49980 |
| Sponsor | University of Toronto (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-49980), Pharmacia (Canada), Pfizer Canada Inc. (Canada) |
- Submission date
- 24/02/2006
- Registration date
- 24/02/2006
- Last edited
- 31/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rita Selby
Scientific
Scientific
Sunnybrook and Women's College
Health Sciences Centre
Room D674a
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
| Phone | +1 416 480 6100 ext 2796 |
|---|---|
| rita.selby@sw.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures. |
| Study acronym | D-KAF |
| Study objectives | To determine the incidence of clinically important venous thromboembolism (VTE) and the efficacy, safety and cost-effectiveness of anticoagulant prophylaxis with a low molecular weight heparin (LMWH) in patients with lower leg fractures requiring surgical repair. |
| Ethics approval(s) | Research Ethics Board, Sunnybrook and Women's College Health Science Centre, Toronto, Ontario, Canada (4 December, 2001). |
| Health condition(s) or problem(s) studied | Isolated below-knee fractures (tibia and/or fibula) requiring surgical repair |
| Intervention | Eligible consenting patients are randomized to receive either LMWH, dalteparin, 5000 anti-X-a units subcutaneously once daily, or placebo, within 72 hours of injury for 14 + 2 days. Patients are investigated for symptomatic VTE with objective diagnostic tests and pre-specified algorithms. All asymptomatic patients are screened with bilateral proximal duplex venous ultrasound at 14 + 2 days and followed up at 6 weeks and 3 months by telephone to assess for development of symptomatic VTE. CBC, INR, aPTT and creatinine are performed at baseline and CBC is repeated at the 14 + 2 day visit to check platelet count. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | LMW heparin, dalteparin |
| Primary outcome measure(s) |
Clinically important venous thromboembolism at 3 months |
| Key secondary outcome measure(s) |
1. Clinically important VTE during the prophylaxis phase (day 0-14 + 2) |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 700 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Sunnybrook and Women's College
Toronto
M4N 3M5
Canada
M4N 3M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2015 | 31/01/2019 | Yes | No |
Editorial Notes
31/01/2019: Publication reference added
