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NCT03903939: SHINE-TRAUMA
Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure
Phase 2 trial testing Iloprost in Multi Organ Failure in 228 participants. Completed in 14 November 2021.
14 November 2021
Quick facts
| Lead sponsor | Pär Johansson |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 22 May 2019 |
| Primary completion | 14 November 2021 |
| Estimated completion | 14 November 2021 |
| Sites | 5 locations across Denmark, Norway |
Drugs / interventions tested
- Iloprost — full drug profile →
- Isotonic saline — full drug profile →
Conditions studied
- Multi Organ Failure — all drugs for Multi Organ Failure →
Sponsor
Pär Johansson
Who can join
18 and older, any sex, with Multi Organ Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Johansson PI, Eriksen CF, Schmal H, Gaarder C, et al · · 2021 · cited 5× · PMID 33393084 · DOI 10.1111/aas.13776
Verify or expand the search:
- PubMed search for NCT03903939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Iloprost
Trials testing the same drug.
- NCT05411107 — Oral Iloprost for the Prevention of Lung Cancer In Former Smokers · Phase 2 · withdrawn
- NCT06319274 — Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure · Phase 2 · recruiting
- NCT04420741 — Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure · Phase 2 · completed
- NCT04123444 — Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure · Phase 2, PHASE3 · completed
- NCT03111212 — Iloprost in Acute Respiratory Distress Syndrome · Phase 3 · completed
Other recruiting trials for Multi Organ Failure
Currently open trials in the same condition.
- NCT05710315 — Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure · NA · recruiting
- NCT05883137 — High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill · recruiting
- NCT06129617 — Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction · NA · recruiting
Other Pär Johansson trials
Trials by the same sponsor.
- NCT06319274 — Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure · Phase 2 · recruiting
- NCT04420741 — Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure · Phase 2 · completed
- NCT03655899 — Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03903939 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pär Johansson
- Last refreshed: 8 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03903939.
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