Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rita Selby

ORCID ID

Contact details

Sunnybrook and Women's College
Health Sciences Centre
Room D674a
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
+1 416 480 6100 ext 2796
rita.selby@sw.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00187408

Protocol/serial number

DCT-49980

Study information

Scientific title

Acronym

D-KAF

Study hypothesis

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

Research Ethics Board, Sunnybrook and Women's College Health Science Centre, Toronto, Ontario, Canada (4 December, 2001).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

LMW heparin, dalteparin

Primary outcome measures

Clinically important venous thromboembolism at 3 months

Secondary outcome measures

1. Clinically important VTE during the prophylaxis phase (day 0-14 + 2)
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)
3. Bleeding
4. Cost-effectiveness

Overall trial start date

01/08/2002

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant 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

Recruitment start date

01/08/2002

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Sunnybrook and Women's College
Toronto
M4N 3M5
Canada

Sponsor information

Organisation

University of Toronto (Canada)

Sponsor details

27 King's College Circle
Toronto
M5S 1A1
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-49980)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pharmacia (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Canada Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes