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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Critical Care Trials Group; Pfizer
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

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