NCT00187408

Brief Summary

It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they may detach and travel to the lungs producing shortness of breath, chest pain, and sometimes death. Unfortunately, it is not known how frequently these complications occur after leg fractures, or if the use of a blood thinner medication can effectively and safely prevent these clots. Doctors at hospitals across Canada are conducting a study in which patients who have surgery for leg fractures receive either a once-daily injection of a blood thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days after their fractures. Neither the patients nor the doctors know which patient is on the medication and which patient is on placebo. All patients receive an ultrasound examination of their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all patients are checked for symptoms of leg or lung clots and any side effects of the medication for 3 months. If the blood thinner is shown to be effective at reducing this complication and documented to be safe and cost-effective in this setting it will be recommended for use in such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to justify the cost or inconvenience of taking this medication, this will also be an important finding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2006

First QC Date

September 13, 2005

Last Update Submit

February 26, 2007

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

ThrombosisPulmonary EmbolismLow Molecular Weight HeparinTibial Fractures

Outcome Measures

Primary Outcomes (1)

  • Clinically important venous thromboembolism at 3 months

Secondary Outcomes (4)

  • Clinically important VTE during the prophylaxis phase

  • Symptomatic VTE (either symptomatic DVT or PE or fatal PE) during the post-prophylaxis phase

  • Bleeding

  • Cost-effectiveness

Interventions

Low Molecular Weight Heparin (dalteparin)DRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 16 years
  • Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
  • Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
  • Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus
  • Combined fractures of the tibia and fibula
  • 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
  • Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission

You may not qualify if:

  • Patients presenting greater than 72 hours after injury
  • Major injury involving other site(s)
  • Lower extremity vascular injury requiring surgical repair
  • Known systemic bleeding disorder or INR \> 1.5, aPTT \> 40 sec, or platelets \< 50 x 109/L at baseline
  • Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
  • Intracranial or other major bleed in the previous 4 weeks
  • Ongoing need for anticoagulation for other reasons
  • Previous DVT or PE (objectively proven or treated with anticoagulants)
  • Known molecular hypercoagulable state
  • Active cancer
  • Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine \> 300 mmol/L)
  • Hypersensitivity to heparin or LMWH (including history of HIT)
  • Inability to arrange out-of-hospital study medication administration
  • Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 ± 2, 6 weeks, 3 months)
  • Inability or refusal to provide informed consent· Previous participation in this study
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

2E3.32 Walter MacKenzie HSC

Edmonton, Alberta, TG6 2R7, Canada

Location

St. Paul's Hospital-Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Hamilton Health Sciences- General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

McMaster University Medical Centre, HSC

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences-Henderson Site

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

North York General Hospital-General Site

Toronto, Ontario, M2K 1E1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

McGill University Health Centre-Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (2)

  • Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

    PMID: 15383478BACKGROUND

  • Selby R, Geerts WH, Kreder HJ, Crowther MA, Kaus L, Sealey F; D-KAF (Dalteparin in Knee-to-Ankle Fracture) Investigators. A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures. J Orthop Trauma. 2015 May;29(5):224-30. doi: 10.1097/BOT.0000000000000250.

    PMID: 25900749DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismThrombosisTibial Fractures

Interventions

Heparin, Low-Molecular-WeightDalteparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismFractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Rita Selby, MBBS, FRCPC

    Sunnybrook & Women's College Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • William Geerts, MD, FRCPC

    Sunybrook & Women's College Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2002

Study Completion

January 1, 2007

Last Updated

February 27, 2007

Record last verified: 2006-02

Locations

CA(13)