Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on P… (NCT03119701) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA
Stopped: IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.
Estonia, Finland40 participantsStarted 2017-02-18
Plain-language summary
A study to assess effectiveness and safety of a drug FP-1201-lyo (Recombinant Human Interferon Beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery for a Ruptured Abdominal Aortic Aneurysm
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room
✓. Patients (male or female) presenting with symptoms of RAAA known to have an infrarenal AAA and proceeding straight to open repair without radiological assessment and confirmed rupture (=retroperitoneal haematoma) in operation
✓. Aneurysma repair must be infra-renal, i.e. the proximal anastomosis must be below the renal arteries and the renal arteries have to stay intact. Temporary above the renal clamping can be used for a maximum of 30 minutes (total clamping time)
✓. Patients providing informed consent
✓. Age of 18 years or higher
Exclusion criteria
✕. Moribund patient not eligible for treatment in ICU or expected to survive surgery
✕. Markedly short life expectancy, e.g. advanced malignant disease
✕. Current participation in another experimental treatment protocol
✕. Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV
✕. Current treatment with Interferon (IFN) alpha or IFN beta
✕. Dialysis therapy for chronic renal failure
✕. Irreversible shock from haemorrhage
What they're measuring
1
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality