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Clinical Trials/NCT02142166
NCT02142166
Unknown
Not Applicable

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

RWTH Aachen University1 site in 1 country310 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aneurysmal Subarachnoid Hemorrhage
Sponsor
RWTH Aachen University
Enrollment
310
Locations
1
Primary Endpoint
Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Albanna

Priv.-Doz. Dr. med. Walid Albanna

RWTH Aachen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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