David A. Garcia, MD
In critically ill patients, is dalteparin more effective than unfractionated heparin (UFH) for reducing incident proximal deep venous thrombosis (DVT)?
Randomized controlled trial (Prophylaxis for Thromboembolism in Critical Care Trial [PROTECT]). ClinicalTrials.gov NCT00182143.
Blinded (patients, family members, clinicians, research personnel, ultrasonographers, and outcome adjudicators).*
To death in hospital or discharge (or at 100 d if still hospitalized).
67 intensive care units (ICUs) in Australia, Brazil, Canada, Saudi Arabia, UK, and USA.
3764 patients > 18 years of age (mean age 61 y, 57% men) who weighed ≥ 45 kg and had an expected ICU stay ≥ 3 days. Exclusion criteria included major trauma, neurosurgery or orthopedic surgery, need for therapeutic anticoagulation, ≥ 3 days of heparin given in the ICU, contraindication to heparin or blood products, pregnancy, and life-support limitation.
Subcutaneous dalteparin, 5000 IU, once daily plus a placebo injection (n = 1880), or UFH, 5000 IU, twice daily (n = 1884) for the duration of ICU stay.
Proximal leg DVT (new-onset symptomatic or asymptomatic thrombosis ≥ 3 d after randomization). Secondary outcomes included any DVT, pulmonary embolism (PE), major bleeding, heparin-induced thrombocytopenia (HIT), and death. With a sample size of 3618, the study had 80% power to detect a 30% reduction in the relative risk of proximal DVT from a baseline risk of 8% (α = 0.05).
99.5% (intention-to-treat analysis).
Dalteparin and UFH did not differ for proximal DVT, any DVT, major bleeding, HIT, or death in hospital (Table). The dalteparin group had a lower rate of PE (Table).
Dalteparin did not differ from unfractionated heparin for reducing proximal deep venous thrombosis in critically ill patients but reduced pulmonary embolism.
Dalteparin vs unfractionated heparin (UFH) in critically ill patients†
†DVT = deep venous thrombosis; HIT = heparin-induced thrombocytopenia; NS = not significant; PE = pulmonary embolism; other abbreviations defined in Glossary. RRR and NNT calculated from control event rates and hazard ratios in article.
Garcia DA. Dalteparin did not differ from unfractionated heparin for reducing proximal DVT in critically ill patients. Ann Intern Med. ;155:JC1–7. doi: 10.7326/0003-4819-155-2-201107190-02007
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Published: Ann Intern Med. 2011;155(2):JC1-7.
Pulmonary/Critical Care, Venous Thromboembolism.
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