aneurysmal subarachnoid hemorrhage MedDRA version: 21.1 Level: PT Classification code 10042316 Term: Subarachnoid haemorrhage System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Dexa inject JENAPHARM
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR.
Concentrat
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, equal or older than 18 years old 2. Written consent to participate in the study by patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the prinicipal investigator is possible) 3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 184 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malfor-mation (AVM), fistula, dissection) 2. Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study 3. Patients with obvious evidence of irreparable brainstem or thalamic injury 4. Patients with foreseeable difficulties to attend follow-ups adequately 5. Subjects with a physical or psychiatric condi-tion which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s par-ticipation in this clinical trial 6. Current positive pregnancy test (e.g. ß-HCG test in serum) 7. Known history of hypersensitivity to the inves-tigational drug or to drugs with a similar chemical structure 8. Severe infectious diseases (in discretion of the local investigator by clinical and laboratory pa-rameters e.g. CRP, PCT, WBC, IL-6) 9. Known angle-closure or open angle glaucoma 10. Known ulceration in the gastro-intestinal tract 11. History of gastro-intestinal bleeding 12. Long-term treatment with corticosteroids prior SAH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze impact on outcome of an anti-inflammatory treatment with dexamethasone in patients with acute aneurysmal subarachnoid hem-orrhage with or without an initial inflammatory sig-nature in peripheral blood compared to placebo;Secondary Objective: 1. Analysis of improvement in survival rate 2. Analysis of improvement in recovery time in patients receiving dexamethasonen after aSAH 3. Analysis of delayed ischemic neurological deficit (DIND) 4. Analysis of symptomatic vasospasm 5. Analysis of inflammation parameters 6. Evaluation of quality of life (QoL) 7. Safety analysis of dexamethasone for treat-ment in patients suffering from SAH ;Primary end point(s): Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS);Timepoint(s) of evaluation of this end point: 6 months after the sub-arachnoid hemorrhage - dichotomized in “favourable (mRS 0-3) versus “unfavourable“ (mRS 4-6) out-come | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison between both treatment arms: 1. a) Analysis of mortality at 7, 90 and 365 days after a SAH b) Comparison of time of death in patients 2. Length of ICU stay and hospitalization after aSAH 3. Delayed ischemic neurological deficit (DIND) 4. Symptomatic vasospasm measured by transcranial doppler/ computed tomography scans/ MR angiography/ angiography 5. Level of inflammation parameters such as CRP, PCT, WBC, IL-6, IL-1ß in serum 6. Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH 7. Analysis of AEs by number, severity, relation-ship ;Timepoint(s) of evaluation of this end point: Analysis of mortality at 7, 90 and 365 days after a SAH Time of death in patients = upon occurrence Length of ICU stay and hospitalization after aSAH = upon occurrence Delayed ischemic neurological deficit (DIND) = upon occurrence Symptomatic vasospasm measured by tran-scranial doppler/ computed tomography scans/ MR angiography/ angiography = Visit 1, 3, 4-22, 25 Inflammation parameters such as CRP, PCT, WBC, IL-6, IL-1ß in serum = Visit 1, 3, 4-22, 23, 25 SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH AEs by number, severity, relationship = every Visit except for Visit 1 and 26 | — |
Countries
Germany
Contacts
Public ContactDr. rer. nat. Marius Krauthausen
Studienzentrale Studienzentrum Bonn
Outcome results
None listed