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Heparin Anticoagulation in Septic Shock

NCT03378466 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2022-05-24

No results posted yet for this study

Summary

This study is a pragmatic open-label international randomized trial comparing therapeutic dose intravenous unfractionated heparin (UFH) to standard care venous thromboprophylaxis in patients diagnosed with septic shock.

Conditions

  • Septic Shock
  • Vasodilatory Shock

Interventions

DRUG

Unfractionated heparin

UFH initiated at 18 IU/kg/hr, dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin (aPTT) of 1.5 to 2.5 times that of the reference aPTT value or anti-Xa values targeted to local practice levels. Duration of study intervention will be a maximum of 5 days (120 hours) or until vasopressors have been discontinued for 24 continuous hours. All participants will then receive venous thromboprophylaxis according to local practice.

OTHER

Venous thromboprophylaxis (VTE)

May include subcutaneous heparin or dalteparin, sequential compression device or graduated compression stockings

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • CancerCare Manitoba

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Ryan Zarychanski, MD MSc · University of Manitoba

  • Anand Kumar, MD · University of Manitoba

  • Dean A Fergusson, PhD MHA · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Greece
  • India
  • Pakistan
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378466 on ClinicalTrials.gov