Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02142166
Acronym
bioSAB
Enrollment
310
Registered
2014-05-20
Start date
2014-04-30
Completion date
2020-12-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

aneurysmal subarachnoid hemorrhage (ASH), biomarker

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.

Interventions

PROCEDUREBiomarker in serum, liquor, micro-dialysate

Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate

PROCEDUREBiomarker in serum and in liquor

Single analysis of biomarker in serum and liquor

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAHEach 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

MeasureTime frameDescription
Clinical outcomeEach participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 monthClinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers
Image morphological outcomeEach participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 monthImage morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers

Countries

Germany

Contacts

Primary ContactWalid Albanna, Priv.-Doz. Dr. med.
walbanna@ukaachen.de+49 241 80 36706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026