The Role of Biomarker in Serum, Cerebrospinal Fluid and Parenchyma in the Context of Aneurysmal Subarachnoid Hemorrhage.

Study Overview
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Brief Summary
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The aim of this study is to improve the usability of biomarkers for the timely prediction of new complications following a cerebral hemorrhage, especially in combination with invasive, functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their immediate and longer-term effectiveness.

Official Title
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Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -

Conditions
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Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
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* Procedure: Biomarker in serum, liquor, micro-dialysate
* Procedure: Biomarker in serum and in liquor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, age ≥ 18 years signed consent for participation in the study signed consent for further analysis of the samples collected during the clinical routine in-patients Exclusion Criteria: female or male patient <18 years pregnancy, lactation lack of signed informed consent for participation in the study lack of signed consent for the further analysis of the samples collected during the clinical routine taking a study drug within the last thirty days Simultaneous participation in another clinical trial (except participation as control group) persons who are in a dependent relationship or employment with the sponsor or investigator persons housed for a judicial or administrative order in an institution

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAB analysis<br>Patients with acute aneurysmal SAH, confirmed by CT or MRI, or lumbar puncture Daily (21 days) analysis of Biomarker in serum, in liquor and in micro-dialysate | Procedure: Biomarker in serum, liquor, micro-dialysate<br>* Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate<br>|
| Experimental: Control<br>Patients who undergo a lumbar puncture for myelography as part of the investigation of a cervical or lumbar foraminal stenosis without cranial or myeläre pathology -or- Patients who receive perioperative prophylactic lumbar drainage without cranial or myeläre pathology Single analysis of Biomarker in serum and liquor | Procedure: Biomarker in serum and in liquor<br>* Single analysis of biomarker in serum and liquor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH | Temporal development of alternative biomarkers in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH, and their response as influenced by the treatment path. | Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Clinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers | Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month | 
| Image morphological outcome | Image morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers | Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysmal subarachnoid hemorrhage (ASH), biomarker