Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA
Condition: Preventive Medicine; Multi Organ Failure
MeSH terms: Multiple Organ Failure
Intervention: Interferon Beta-1A; Placebo
Intervention description: Lyophilisate for solution for injection.; Lyophilisate for solution for injection as placebo.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicentre, randomised, double-blinded, Phase II, parallel group comparison study of the efficacy and safety of FP-1201-lyo compared to placebo in patients surviving emergency open surgery for an infra-renal ruptured abdominal aortic aneurysm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients Surviving Open Surgery; Ruptured Abdominal Aortic Aneurysm

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
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion into this study, each patient must fulfil the following
        inclusion criteria during screening and prior to the first dose of study medication being
        administered on D0 (criteria 1 or 2 and all 3, 4 and 5):

          1. Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA)
             diagnosed by ultrasound or CT-scan in the emergency room

               -  all forms of infrarenal RAAAs with or without coexisting iliac aneurysms are
                  included or

          2. 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

             and

          3. 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)

             and

          4. Patients providing informed consent

             and

          5. Age of 18 years or higher

        Exclusion Criteria:

        To be eligible for inclusion into this study, each patient must not meet any of the
        following exclusion criteria during screening or prior to the first dose of study
        medication being administered:

          1. Moribund patient not eligible for treatment in ICU or expected to survive surgery

          2. Markedly short life expectancy, e.g. advanced malignant disease

          3. Current participation in another experimental treatment protocol

          4. Significant congestive heart failure, defined as New York Heart Association (NYHA)
             class IV

          5. Current treatment with Interferon (IFN) alpha or IFN beta

          6. Dialysis therapy for chronic renal failure

          7. Irreversible shock from haemorrhage

          8. Unconsciousness or inability to give consent

          9. Ruptured Endovascular Aortic Repair (rEVAR) first (prior attempt for endovascular
             aortic repair for the current rupture)

         10. Diagnosed cirrhosis

         11. Pregnancy and women with child bearing potential without negative pregnancy test

         12. Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded)

         13. RAAA requiring repair of the renal arteries or the proximal aorta

               -  thoracoabdominal aneurysms requiring immediate repair

               -  damaged renal arteries during emergency clamping requiring repair

        Note:

          -  temporary clamping above the renal arteries (max 30 min total clamping time above the
             renal arteries) does not lead to exclusion

          -  ligation of the left renal vein does not lead to exclusion