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

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Biomarker in serum, liquor, micro-dialysate

Biomarker in serum and in liquor

About this trial

This is an interventional prevention trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring aneurysmal subarachnoid hemorrhage (ASH), biomarker

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Neurosurgery, University Hospital RWTH AachenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SAB analysis

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical outcome

Clinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers

Image morphological outcome

Image morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers

Full Information

NCT ID

NCT02142166

First Posted

April 30, 2014

Last Updated

January 31, 2020

Sponsor

RWTH Aachen University

1. Study Identification

Unique Protocol Identification Number

NCT02142166

Brief Title

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

Acronym

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 -

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RWTH Aachen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysmal Subarachnoid Hemorrhage

Keywords

aneurysmal subarachnoid hemorrhage (ASH), biomarker

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SAB analysis

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Biomarker in serum, liquor, micro-dialysate

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Biomarker in serum and in liquor

Intervention Description

Single analysis of biomarker in serum and liquor

Primary Outcome Measure Information:

Title

Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH

Description

Temporal development of alternative biomarkers in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH, and their response as influenced by the treatment path.

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.

Secondary Outcome Measure Information:

Title

Clinical outcome

Description

Clinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers

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

Title

Image morphological outcome

Description

Image morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Walid Albanna, Priv.-Doz. Dr. med.

Phone

+49 241 80 36706

walbanna@ukaachen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walid Albanna, Priv.-Doz. Dr. med.

Organizational Affiliation

Department of Neurosurgery, University Hospital RWTH Aachen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurosurgery, University Hospital RWTH Aachen

City

Aachen

State/Province

NRW

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerrit A. Schubert, PD. Dr.

Phone

+492418088481

gschubert@ukaachen.de

First Name & Middle Initial & Last Name & Degree

Gerrit A. Schubert, PD. Dr.

First Name & Middle Initial & Last Name & Degree

Walid Albanna, Priv.-Doz. Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

35260962

Citation

Veldeman M, Weiss M, Albanna W, Nikoubashman O, Schulze-Steinen H, Clusmann H, Hoellig A, Schubert GA. Incremental Versus Immediate Induction of Hypertension in the Treatment of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage. Neurocrit Care. 2022 Jun;36(3):702-714. doi: 10.1007/s12028-022-01466-7. Epub 2022 Mar 8.

Results Reference

derived

PubMed Identifier

34604940

Citation

Conzen C, Weiss M, Albanna W, Seyfried K, Schmidt TP, Nikoubashman O, Stoppe C, Clusmann H, Schubert GA. Baseline characteristics and outcome for aneurysmal versus non-aneurysmal subarachnoid hemorrhage: a prospective cohort study. Neurosurg Rev. 2022 Apr;45(2):1413-1420. doi: 10.1007/s10143-021-01650-x. Epub 2021 Oct 4.

Results Reference

derived

PubMed Identifier

33866464

Citation

Veldeman M, Weiss M, Simon TP, Hoellig A, Clusmann H, Albanna W. Body mass index and leptin levels in serum and cerebrospinal fluid in relation to delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2021 Dec;44(6):3547-3556. doi: 10.1007/s10143-021-01541-1. Epub 2021 Apr 17.

Results Reference

derived

PubMed Identifier

32886914

Citation

Veldeman M, Lepore D, Hollig A, Clusmann H, Stoppe C, Schubert GA, Albanna W. Procalcitonin in the context of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2020 Sep 4;135(1):29-37. doi: 10.3171/2020.5.JNS201337.

Results Reference

derived

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

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