TerminatedPhase 2

Heparin Anticoagulation in Septic Shock

Stopped: infeasible to continue due-to inability to recruit during the COVID-19 pandemic and grants coming to an end.

United States, Brazil178 participantsStarted 2018-03-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Creatinine ≥1.5x the known baseline creatinine, or ≥ 26.5 µmol/L increase or \<0.5 mL/kg of urine output for 6-12 hours according to the KDIGO \[Kidney Disease improving Global Outcomes (KDiGO)\] guideline definition of acute kidney injury.
✓. Need for invasive mechanical ventilation or a P/F ratio \<250
✓. Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrolment
✓. Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \> 4.0 mmol/L

Exclusion criteria

✕. Clinical: Active bleeding; head trauma; intracranial surgery or stroke within 3 months; history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system; history of a bleeding diatheses; gastrointestinal bleeding within 6 weeks; presence of an epidural or spinal catheter; selected cases of recent surgery where IV therapeutic UFH is considered contraindicated
✕. Laboratory: Platelet count \<50 x109/L, INR \>2.0, or baseline aPTT \>50 seconds prior to enrolment

What they're measuring

Vasopressor-free days.

Timeframe: 30 days

Trial details

NCT IDNCT03378466

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

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