Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138099
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : June 1, 2007
Canadian Critical Care Trials Group
Information provided by:
McMaster University

Brief Summary:

The investigators' primary research objective is:

  • To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:

    • the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis;
    • the risk of major bleeding during the treatment period.

The investigators' secondary research objectives are:

  • To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency;
  • To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa > 0.10 IU/mL);
  • To estimate the relationship between trough anti-Xa levels and bleeding.

The DIRECT Pilot Study:

Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.

Condition or disease Intervention/treatment
Renal Insufficiency Drug: Fragmin (dalteparin sodium)

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)
Study Start Date : July 2004
Actual Study Completion Date : June 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patient aged > 18 years
  • Admitted to an ICU with an expected ICU length of stay > 72 hours
  • Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2

Exclusion Criteria:

  • ICU admission for > 2 weeks at time of screening
  • ICU admission within 3 months of cardiac surgery or neurosurgery
  • Active bleeding or at high risk for bleeding complications
  • Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening
  • Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening
  • Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours
  • Receipt of > 2 doses of LMWH (prophylactic- or therapeutic-dose) in the ICU
  • Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening
  • Receiving dialysis that requires anticoagulation (eg., PRISMA, slow continuous ultrafiltration [SCUF]) at time of screening
  • Weight < 45 kg
  • Woman who is pregnant or lactating
  • Bilateral lower limb amputation
  • Previous adverse reaction to heparin or LMWH (eg., allergy, heparin-induced thrombocytopenia [HIT])
  • Contraindication to receiving blood products
  • Life expectancy < 14 days or receiving palliative care
  • Prior enrolment in this study or enrolment in a concurrent related clinical trial
  • Patient or surrogate decision-maker does not provide consent to participate in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00138099

Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Hamilton Health Science Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Science Centre - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
St Joseph's HealthCare
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Science Centre - Henderson Hospital
Hamilton, Ontario, Canada, L8V 1C3
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Civic Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hopital Sacre Couer
Montreal, Quebec, Canada, H4J 2C5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Critical Care Trials Group
Principal Investigator: James Douketis, MD McMaster University
Principal Investigator: Deborah J Cook, MD McMaster University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00138099     History of Changes
Other Study ID Numbers: 092103
File No: 9427-M1133-21C
Control No: 092103
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: November 2006

Keywords provided by McMaster University:
Critically ill patients (ICU)
Deep Venous Thromboembolism prevention
Renal Failure
Critically ill

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action