Subarachnoid Hemorrhage Clinical Trial
Official title:
MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Group 1-3: - Uncertainty < 24 times on time of ictus Inclusion Criteria Group 1-2: - Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain. Inclusion Criteria Group 3: - Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain. Exclusion Criteria Group 1-3: - Transfer to other hospital within 5 days of admission |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delayed Cerebral Ischemia | Delayed Cerebral Ischemia as defined by Vergouwen et al[1]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures. Comparing microRNA profiles between groups with or without. |
21 days | No |
Primary | Delayed Cerebral Ischemia and Cerebral infarction | as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days | No |
Primary | Delayed Cerebral infarction | as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days | No |
Secondary | Acute Lung Injury | as defined by Kahn et al[2]. Comparing microRNA profiles between groups with or without |
21 days | No |
Secondary | Cardiac Dysfunction | Evaluated by transthoracic echocardiography Comparing microRNA profiles between groups with or without |
21 days | No |
Secondary | Systemic Inflammatory Response Syndrome | Evaluated through daily vital signs and biochemistry Comparing microRNA profiles between groups with or without |
21 days | No |
Secondary | Early Brain Injury | Early Brain injury = GCS 3-12 and/or paresis (degree 4) of at least one extremity or aphasia No Early Brain injury = GCS 13-15 and no or only small and mild focal deficit Comparing microRNA profiles between groups with or without |
Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated) | No |
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