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

This study has been completed.
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Pfizer
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00138099
First received: August 29, 2005
Last updated: May 30, 2007
Last verified: November 2006
  Purpose

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 Intervention Phase
Renal Insufficiency
Drug: Fragmin (dalteparin sodium)
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Enrollment: 140
Study Start Date: July 2004
Study Completion Date: June 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138099

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
St Joseph's HealthCare
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Science Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Science Centre - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
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
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
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 Sacre Couer
Montreal, Quebec, Canada, H4J 2C5
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Critical Care Trials Group
Pfizer
Investigators
Principal Investigator: James Douketis, MD McMaster University
Principal Investigator: Deborah J Cook, MD McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00138099     History of Changes
Other Study ID Numbers: 092103, File No: 9427-M1133-21C, Control No: 092103
Study First Received: August 29, 2005
Last Updated: May 30, 2007
Health Authority: Canada: Health Canada

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
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014