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

January 31, 2020 updated by: Walid Albanna, RWTH Aachen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Walid Albanna, Priv.-Doz. Dr. med.
  • Phone Number: +49 241 80 36706
  • Email: walbanna@ukaachen.de

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • Department of Neurosurgery, University Hospital RWTH Aachen
        • Contact:
        • Sub-Investigator:
          • Gerrit A. Schubert, PD. Dr.
        • Principal Investigator:
          • Walid Albanna, Priv.-Doz. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAB analysis

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

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
Procedure: Biomarker in serum and in liquor
Single analysis of biomarker in serum and liquor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
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
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
Image morphological outcome
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Walid Albanna, Priv.-Doz. Dr. med., Department of Neurosurgery, University Hospital RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-A 14-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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