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

RWTH Aachen University

Status: Unknown

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Procedure: Biomarker in serum, liquor, micro-dialysate; Procedure: Biomarker in serum and in liquor

Study type: Interventional

Funder types: Other

Identifiers

NCT02142166

CTC-A 14-004

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

SAB analysis

Experimental group

Description:

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

Treatment:

Procedure: Biomarker in serum, liquor, micro-dialysate

Control

Experimental group

Description:

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

Treatment:

Procedure: Biomarker in serum and in liquor