Status:
COMPLETED
Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Critical Care Trials Group
Pfizer
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
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 pati...
Detailed Description
Critically ill patients who are admitted to an intensive care unit (ICU) are at high risk for deep vein thrombosis (DVT), with an estimated 20-40% of patients developing DVT without prophylaxis. Preve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00138099
Start Date
July 1 2004
End Date
June 1 2006
Last Update
June 1 2007
Active Locations (14)
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1
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
2
Hamilton Health Science Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
3
Hamilton Health Science Centre - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
4
St Joseph's HealthCare
Hamilton, Ontario, Canada, L8N 4A6