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

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 Time Perspective: Prospective
Official Title:	Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Dalteparin sodium

U.S. FDA Resources

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

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):

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. Epub 2009 Mar 27.

Douketis J, Cook D, Meade M, Guyatt G, Geerts W, Skrobik Y, Albert M, Granton J, Hébert 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.

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. Epub 2008 Mar 3.

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 May 22, 2013