BENEFIT OF ANTI-COAGULATION THERAPY IN PATIENTS WITH SEPTIC SHOCK.

Phase 1

• Conditions: HEPARIN Anticoagulation to improve outcomes in septic shock : the HALO International Phase II RCT; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-003726-93-GR
• Lead Sponsor: HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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 <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.
b.) Need for invasive mechanical ventilation or a P/F ratio <250
c.) Platelets <100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment
d.) Arterial pH < 7.30 or base deficit > 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

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 <30 x109/L, INR >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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