Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure

NCT03903939 | Completed Phase 2

• 2 other identifiers: SHINE-TRAUMA2019-000936-24
• Study Type: interventional
• Target: 228
• Locations: 2 countries
• Sites: 5

Brief Summary

A multicenter, randomized (1:1, iloprost: placebo), placebo controlled, blinded, investigator-initiated phase 2b trial in trauma patients with haemorrhagic shock and shock induced endotheliopathy (SHINE), investigating the efficacy and safety of continuous intravenous administrating of iloprost (1 ng/kg/min) versus placebo for 72-hours, in a total of 220 patients. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in trauma patients with haemorrhagic shock (SHINE) suffering from organ failure caused by endothelial breakdown, ultimately improving survival.

Conditions

Multi Organ Failure

Keywords

Trauma patients; Shock-induced endotheliopathy

Outcome Measures

Primary Outcomes (1)

• ICU free days

  Defined as the number of days spend alive out of the ICU to day 28. Patients who dies on or prior to day 28 during their initial ICU stay are assigned zero in ICU free days

  28 days after admission

Secondary Outcomes (6)

• All-cause mortality

  90 days after admission

• Hospital length of stay

  90 days after admission

• Vasopressor free days

  28 days after admission

• Ventilator free days

  28 days after admission

• Renal replacement free days

  28 days after admission

Study Arms (2)

Iloprost

EXPERIMENTAL

Patients randomized to active treatment (n = 110 patients) will receive continuous infusion of iloprost for 72 hours after inclusion or until discharge to ward or death, whichever comes first

Drug: Iloprost

Placebo

PLACEBO COMPARATOR

Patients randomized to placebo treatment (n= 110 patients) will receive continuous infusion of isotonic saline (equal volume) for 72 hours after inclusion or until discharge to ward or death, whichever comes first.

Drug: Isotonic saline

Interventions

Iloprost DRUG

continuously infusion for 72 hours 1 ng/kg/min

Also known as: Intervention

Iloprost

Isotonic saline DRUG

continuously infusion for 72 hours equal volume to Iloprost

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Present with clinical signs of hemorrhagic shock (defined by systolic blood pressure \<90 millimetre of mercury (mmHg) or use of pre-hospital blood transfusion).
• Activation of local massive transfusion protocol and initiation of the first transfusion after admission.
• Randomised within 5 hours of injury and 3 hours of admission to the emergency department of the participating trial site.
• Consent is provided on behalf of incapacitated patients by Scientific Guardian

You may not qualify if:

• Withdrawal from active therapy
• Known hypersensitivity to Iloprost.
• Pregnancy (non-pregnancy confirmed by patient having a negative urine or plasma choriogonadotropin (hCG) or being postmenopausal defined as females at 60 years old and beyond)
• Known severe heart failure (New York Heart Association (NYHA) class IV)
• Suspected acute coronary syndrome
• Estimated weight \< 40 kg

Sponsors & Collaborators

• Pär Johansson: lead
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (5)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet (University of Copenhagen)

Copenhagen, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (1)

• Johansson PI, Eriksen CF, Schmal H, Gaarder C, Pall M, Henriksen HH, Bovbjerg P, Lange T, Naess PA, Nielsen C, Kirkegaard H, Stensballe J. Efficacy and safety of iloprost in trauma patients with haemorrhagic shock-induced endotheliopathy-Protocol for the multicentre randomized, placebo-controlled, blinded, investigator-initiated shine-trauma trial. Acta Anaesthesiol Scand. 2021 Apr;65(4):551-557. doi: 10.1111/aas.13776. Epub 2021 Jan 11.

  PMID: 33393084 DERIVED

Related Links

• Publication of results

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

Iloprost; Methods; Sodium Chloride

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pär I Johansson, MD, MPA

  University of Copenhagen (Rigshospitalet)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patient, investigator and outcome assessor will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor, Head of Section for Transfusion Medicine

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: May 22, 2019
• Primary Completion: November 14, 2021
• Study Completion: November 14, 2021
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4); NO (1)