NCT00138099

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

14 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

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 1, 2007

Status Verified

November 1, 2006

First QC Date

August 29, 2005

Last Update Submit

May 30, 2007

Conditions

Renal Insufficiency

Keywords

Critically ill patients (ICU)Deep Venous Thromboembolism preventionRenal FailureCritically ill

Interventions

Fragmin (dalteparin sodium)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Science Centre - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Science Centre - McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

St Joseph's HealthCare

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Science Centre - Henderson Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook and Women's College Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Sacre Couer

Montreal, Quebec, H4J 2C5, Canada

Location

Related Publications (3)

  • Cook D, Sinuff T, Zytaruk N, Rabbat C, Lee A, O'Donnell M, Thabane L, Linkins L, Treleaven D, Patel R, Meade M, Crowther M, Marshall JC, Douketis J; DIRECT Investigators and Canadian Critical Care Trials Group. Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis. J Crit Care. 2009 Jun;24(2):168-75. doi: 10.1016/j.jcrc.2009.01.010. Epub 2009 Mar 27.

    PMID: 19327956DERIVED

  • Douketis J, Cook D, Meade M, Guyatt G, Geerts W, Skrobik Y, Albert M, Granton J, Hebert P, Pagliarello G, Marshall J, Fowler R, Freitag A, Rabbat C, Anderson D, Zytaruk N, Heels-Ansdell D, Crowther M; Canadian Critical Care Trials Group. Prophylaxis against deep vein thrombosis in critically ill patients with severe renal insufficiency with the low-molecular-weight heparin dalteparin: an assessment of safety and pharmacodynamics: the DIRECT study. Arch Intern Med. 2008 Sep 8;168(16):1805-12. doi: 10.1001/archinte.168.16.1805.

    PMID: 18779469DERIVED

  • Cook D, Douketis J, Meade M, Guyatt G, Zytaruk N, Granton J, Skrobik Y, Albert M, Fowler R, Hebert P, Pagliarello G, Friedrich J, Freitag A, Karachi T, Rabbat C, Heels-Ansdell D, Geerts W, Crowther M; Canadian Critical Care Trials Group. Venous thromboembolism and bleeding in critically ill patients with severe renal insufficiency receiving dalteparin thromboprophylaxis: prevalence, incidence and risk factors. Crit Care. 2008;12(2):R32. doi: 10.1186/cc6810. Epub 2008 Mar 3.

    PMID: 18315876DERIVED

MeSH Terms

Conditions

Renal InsufficiencyCritical Illness

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • James Douketis, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Deborah J Cook, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

July 1, 2004

Study Completion

June 1, 2006

Last Updated

June 1, 2007

Record last verified: 2006-11

Locations

CA(14)