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Trial record 20 of 195 for:    Hemorrhage AND SAH

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

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ClinicalTrials.gov Identifier: NCT02142166
Recruitment Status : Unknown
Verified September 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : May 20, 2014
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Procedure: Biomarker in serum, liquor, micro-dialysate Procedure: Biomarker in serum and in liquor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -
Study Start Date : April 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142166


Contacts
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Contact: Gerrit A. Schubert, PD. Dr. +492418088481 gschubert@ukaachen.de

Locations
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Germany
Department of Neurosurgery, University Hospital RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Gerrit A. Schubert, PD. Dr.    +492418088481    gschubert@ukaachen.de   
Principal Investigator: Gerrit A. Schubert, PD. Dr.         
Sub-Investigator: Walid Albanna, Dr.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Gerrit A. Schubert, PD. Dr. Department of Neurosurgery, University Hospital RWTH Aachen

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02142166     History of Changes
Other Study ID Numbers: CTC-A 14-004
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
aneurysmal subarachnoid hemorrhage (ASH)
biomarker

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions