Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03903939 |
Other study ID # |
SHINE-TRAUMA |
Secondary ID |
2019-000936-24 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 22, 2019 |
Est. completion date |
November 14, 2021 |
Study information
Verified date |
May 2024 |
Source |
Rigshospitalet, Denmark |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The main objective in this trial is to investigate whether continuous infusion of iloprost at
a dose of 1 ng/kg/min for 72-hours is safe and significantly increase the number of intensive
care unit (ICU) free days, within 28 days from admission compared to infusion of placebo in
trauma patients with haemorrhagic shock and SHINE.
Patients are presented at the investigator site in an acute critical condition and therefore
informed consent will be obtained from a scientific guardian. Next-of-kin and subsequently
the patient will co-sign as soon as possible. During the trial additional blood samples will
be obtained daily for the first 72 hours. Patients will be observed and assessed
continuously. During the extended follow up period at day 28 and 90, no contact will be made
to the patient, but the data will be collected from department/hospital databases to
establish length of stay and potential mortality.
The trial is conducted in accordance with the Helsinki 2 declaration and International
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,
Guideline for Good Clinical Practice (ICH-GCP) and in compliance with the protocol. As part
of the quality assurance site monitoring will be performed by an independent GCP-Unit
including source data verification. Standard Operation Procedure to address protocol specific
procedures such as data collection and adverse event reporting are developed.
The power calculation is based on not yet published data from the following trial
'Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy
(iTACTIC)' [NTC 02593877] having the same in- and exclusion criteria as the present trial.
The number of ICU free days within 30-days from admission is chosen as the primary endpoint
and a clinically relevant increase in ICU free days within 28-days of 30% with α 0.05, power
0.85 will require 107 patients in each 1:1 randomization group. We plan on including 110
patients in each group and 220 in total. The final statistical analysis plan will be
published before the last patient is included in the trial and analysis of the data from the
randomized trial will be performed by Theis Lange, Associate Professor, Section of
Biostatistics, Department of Public Health, University of Copenhagen.
The primary end point will be analyzed using linear regression adjusted for site. Effect size
will be summarized using adjusted mean differences with confidence intervals based on robust
standard errors as residuals are not expected to be normally distributed. The same analysis
will be employed to continuous secondary outcomes. All-cause mortality will be further
illustrated using Kaplan-Meier curves. All analysis will be conducted following the intention
to treat principle (this will be the primary analysis) and per-protocol. In addition, the
following patient subgroup will also be analyzed separately:
• Patients with traumatic brain injury