HEPARIN Anticoagulation to improve outcomes in septic shock : the HALO International Phase II RCT MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: HEPARIN/LEO INJ.SOL 25000IU/5ML VIAL BTx10VIALSx5ML
Pharmaceutical Form: Solution for injection
Sponsors
HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 18 years of age 2. 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. 3. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following: a.) Creatinine =1.5x the known baseline creatinine, or = 26.5 µmol/l increase or 5 mmol/L in association with a lactate >/= to 4.0 mmol/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: We will exclude patients who have any one of the following criteria at the time of enrolment: 1. Other forms of shock including cardiogenic, hemorrhagic, hypovolemic, neurogenic, or obstructive shock. 2. Received vasopressor therapy for greater than 18 hours prior to enrolment 3. Bleeding Risk: a. 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 b. Laboratory: Platelet count 2.0, or baseline aPTT >50 sec prior to enrollment 4. Known or suspected adverse reaction to UFH including heparin induced thrombocytopenia (HIT). 5. 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 (used within 7 days before study entry AND if the INR exceeds 2.0 at enrolment); thrombolytic therapy within 3 previous days 6. Terminal illness with a life expectancy of less than 3 months, or no commitment to aggressive care 7. Consent declined from patient or substitute decision-maker 8. Physician refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Intravenous (IV) unfractionated heparin (UFH) reduces mortality and morbidity when administered to patients with suspected septic shock.;Secondary Objective: Clinical: ICU, hospital and 60-day mortality; change in the multiple organ dysfunction scoring system (? MODS) hospital-free days to day 90 and; renal replacement therapy-free days to day 28.;Primary end point(s): The primary outcome of efficacy is vasopressor-free days. ;Timepoint(s) of evaluation of this end point: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ICU, hospital and 60-day mortality; change in the multiple organ dysfunction scoring system (? MODS) hospital-free days to day 90 and; renal replacement therapy-free days to day 28.;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
Brazil, Canada, Greece, India, Pakistan, United States
Contacts
Public ContactSECRETARY OF THE BOARD
HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
Outcome results
None listed