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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— bioSAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02142166
• Other study ID #: CTC-A 14-004
• Status: Recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: RWTH Aachen University
• Contact: Walid Albanna, Priv.-Doz. Dr. med.
• Phone: +49 241 80 36706
• Email: walbanna[@]ukaachen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Procedure:
• Biomarker in serum, liquor, micro-dialysate
Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate
• Biomarker in serum and in liquor
Single analysis of biomarker in serum and liquor

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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