Publication Date:
2004-11-16
Description:
Rationale: No published randomized trials have compared low molecular weight heparin (LMWH) to unfractionated heparin (UFH) for thromboprophylaxis in medical-surgical ICU patients. Objectives: A) Our Feasibility Objectives were to assess: 1) timely enrollment and complete, blinded study drug administration, 2) LMWH bioaccumulation in renal insufficiency, 3) twice weekly leg ultrasounds, and 4) recruitment rates for a future trial. B) Our Clinical Objectives were to assess 1) the effectiveness of LMWH vs UFH by estimating DVT, and pulmonary embolism (PE) rates, and 2) the safety of LMWH vs UFH regarding bleeding, thrombocytopenia and HIT. Methods: In this prospective randomized stratified concealed blinded multicenter trial, we included patients ≥18 with expected ICU stay ≥72h. We excluded trauma, orthopaedic, cardiac, or neurosurgery, severe hypertension, DVT, PE or hemorrhage within 3 mos, INR 〉2ULN, PTT 〉2ULN, platelets 99% of scheduled doses; every dose was blinded. 2) No LWMH bioaccumulation was observed as measured by anti-Xa levels when creatinine clearance decreased to
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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