Heparin in Severe Sepsis

Phase 2

• Conditions: Severe sepsis; Blood - Other blood disorders

• Registration Number: ACTRN12607000157471
• Lead Sponsor: Dr Megan S Robertson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosis of severe sepsis 2. Patients able commence study treatment within 24 hours of fulfilling inclusion criteria. 3. Informed consent obtained from the patient or next of kin/legal surrogate.

Exclusion Criteria

1. Patient is receiving continued full anticoagulation treatment for any other reason with either unfractionated heparin (UFH) or coumarin agents2. Patients with contra-indication to low dose UFH or fondaparinux including intracranial haemorrhage, active bleeding or heparin induced thrombocytopaenia(HIT) in the past 3 months.3. Patients with prior adverse reaction to UFH or fondaparinux4. Patients with organ dysfunction due to sepsis present for more than 24 hours5. Patients not for full active treatment, except presence of DNR order.6. Patients not expected to survive 28 days due to underlying or comorbid condition.7. Patient is moribund with death or brain death expected within 24 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survivial from severe sepsis.[At 28 days after randmisation];All cause mortality[At 28 days after randmisation]

Secondary Outcome Measures

Name	Time	Method
Death from all causes[At 90 days after randomisation];Death in Intensive Care Unit (ICU) [28 days after randomisation and at hospital discharge];ICU and hospital length of stay[Whilst in ICU and hospital];The need for and duration of organ support(inotropic/vassopressor/mechanical ventilation) measured daily whilst in ICU.[Measured daily whilst an inpatient in ICU];Adverse events related to drug safety, particularly bleeding episodes, monitored daily.[Monitored daily till death or 90 days post randomisation]