The pharmacodynamics of unfractionated heparin and fondaparinux in critically ill patients with severe sepsis.
Dr M Robertson
15 participants
Jul 1, 2006
Interventional
Conditions
Summary
Given the significant incidence of deep venous thromboses (DVT) in critically ill patients and the failure of current prophylactic regimens to fully prevent DVT, additional pharmacokinetic information regarding the efficacy of heparin and fondaparinux in critically ill patients is required. We aim to assess the bioavailability of heparin administered subcutaneously and intravenously and fondaparinux administered subcutaneously in a cohort of critically ill patients with severe sepsis.
Eligibility
Exclusion Criteria1
- Patients will be excluded if, in the opinion or knowledge of the responsible clinician, any of the following criteria apply: 1. Patients aged less than 18 years. 2. Patient is receiving continued full anticoagulation treatment for another reason with either heparin or coumarin agents. 3. Patients with a contra-indication to low-dose heparin including intracranial haemorrhage, active bleeding, or Heparin induced Thrombcytopenia (HIT) in the past 3 months. 4. Patients with a prior adverse reaction to heparin. 5. Patients or next-of-kin do not consent to inclusion in the study.
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Interventions
This is a pharmacokinetic study to assess the bioavailability of heparin and fondaparinux (blood thinning agents) in Intensive care Unit (ICU) patients with sepsis. The bioavailability of these blood thinning agents will be measured by blood tests of the factor Xa inhibition during the 72 hour study period. Patients will be randomised to receive the three anticoagulant (blood thinning) regimens sequentially and have repeated tests of the inhibition of factor Xa activity. The three heparin regimes to be assessed are: 1. Heparin 5000 Units administered subcutaneously twice daily. 2. Heparin 10 000 Units intravenously over 24 hours. 3. Fondaparinux 2.5 mg subcutaneously once daily.
Locations(1)
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ACTRN12606000285550