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

Not Applicable

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: Biomarker in serum, liquor, micro-dialysate; Procedure: Biomarker in serum and in liquor

• Registration Number: NCT02142166
• Lead Sponsor: RWTH Aachen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAB analysis	Biomarker in serum, liquor, micro-dialysate	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
Control	Biomarker in serum and in liquor	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurosurgery, University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany