Heparin Anticoagulation in Septic Shock

Stopped early · Phase 2

Conditions studied: Septic Shock, Vasodilatory Shock

In brief

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.

Key facts

Study ID

NCT03378466

Run by

University of Manitoba

People needed

178

Starts

2018-03-12

Expected to finish

2021-12-31

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Refractory hypotension documented within 18 hours prior to enrolment that requires the institution and ongoing use of vasopressor agents, (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine >5 mcg/kg/min) at the time of enrolment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mm Hg, or a systolic blood pressure more than 30 mm Hg below baseline, or a mean arterial pressure (MAP) less than 65 mm Hg and receipt of ≥ 2 litres of intravenous fluid for the treatment of hypotension (≥ 1 litre if dialysis dependent end-stage renal disease or if the patient is felt to be in congestive heart failure).
• At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following:
• 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

You may not qualify if…

• Other forms of shock including cardiogenic, hemorrhagic, hypovolemic, neurogenic, or obstructive shock.
• Clinical suspicion or confirmation of a viral hemorrhagic shock syndrome including, but not limited to, dengue fever
• Rapid clinical improvement; vasopressors likely to be discontinued in the next 6 hours
• Received vasopressor therapy for greater than 18 hours prior to enrolment
• Bleeding Risk:
• 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
• Known or suspected adverse reaction to UFH including heparin induced thrombocytopenia (HIT).
• Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before enrolment; LMWH at a higher dose than recommended for prophylactic use within 12 hours before the infusion; warfarin (if used within 7 days before study entry AND if the INR exceeds 2.0 at enrolment); thrombolytic therapy within 3 previous days; use of IIb/IIIa inhibitors within the previous 7 days.
• Need for therapeutic anticoagulation
• Terminal illness with a life expectancy of less than 3 months, or no commitment to aggressive care.
• Consent declined from patient or authorized 3rd party
• Physician refusal

Where it is running

• Hospital Sao Jose — Altamira, Brazil
• Hospital Novo Atibaia — Atibaia, Brazil
• Hospital de Amor (Barretos) — Barretos, Brazil
• Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Brazil
• Hospital Tacchini — Bento Gonçalves, Brazil
• Hospital de Brasília — Brasília, Brazil
• Hospital Ortopedico e Medicina Especializada ltda. - HOME — Brasília, Brazil
• Instituto de Cardiologia do Distrito Federal — Brasília, Brazil
• Hospital Maternidade São José — Colatina, Brazil
• Hospital Baía Sul — Florianópolis, Brazil
• Hospital Nereu Ramos — Florianópolis, Brazil
• Hospital de Amor Jales — Jales, Brazil
• Unimed Cariri Hospital — Juazeiro do Norte, Brazil
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil
• Irmandade da Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Brazil
• Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto — Ribeirão Preto, Brazil
• Hospital Bruno Born — Rio Grande, Brazil
• Hospital da Cidade — Salvador, Brazil
• Santa Casa de São João Del Rei — São João del Rei, Brazil
• Hospital AC Camargo — São Paulo, Brazil
• Hospital Beneficência Portuguesa — São Paulo, Brazil
• Hospital da Luz — São Paulo, Brazil
• Hospital das Clinicas da faculdade de Medicina de Universidade de São Paulo — São Paulo, Brazil
• Hospital e Maternidade Sao Vicente — São Paulo, Brazil
• Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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