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Neutrophil Extracellular Traps in Stroke (NET-STROKE)

Organizational Data

DRKS-ID:
DRKS00030601
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-01-02
Last update in DRKS:
2024-01-31
Registration type:
Prospective

Acronym/abbreviation of the study

NET-STROKE

URL of the study

No Entry

Brief summary in lay language

The aim of the NET-STROKE study is to evalute if Neutrophil extracellular traps (NETs) are involved in the pathophysiology of stroke. We will analyze if NET can be detected in the peripheral blood of patients with ischemic and hemorrhagic stroke (brain bleeding) and, if detectable, if these markers correlate with functional outcome of patients and imaging paramethers. Furthermore, we will analyze if there are differences between ischemic and hemorrhagic stroke. In a subgroup of patients with intraventrucular bleeding and an extraventricular drainage we will analyze NETs in cerebrospinal fluid. NET-STROKE will be prospective, single-center study conducted at the University Hospital Augsburg, Germany.

Brief summary in scientific language

Ischemic and hemorrhagic stroke often results in death or severe disability. Intravenous thrombolysis and endovascular thrombectomy are effective treatment options in patients with acute ischemic stroke; however, similarly effective therapies are not available for hemorrhagic stroke. Secondary molecular and cellular mechanisms contribute to the clinical course and functional outcome of stroke patients, including impaired function of the blood-brain-barrier and inflammatory processes. These processes contribute to the development of brain tissue edema and secondary brain tissue damage, which may result in clinically relevant life-threatening intracranial mass effects (space-occupying infarction, perifocal edema) within the first days after stroke onset. The role of neutrophil extracellular traps (NETs) in stroke is largely unknown. NETs are bundles of extracellular neutrophilic DNA decorated with neutrophilic proteins induced by activated neutrophils. In its physiologic role, these NETs trap and kill bacteria, and thereby have beneficial function as a defense mechanism against pathogens; beyond that, they play a role in pathologic processes, e.g., in arterial and venous thrombosis. NETs are a prime candidate mechanism to potentially explain the link between neutrophilic inflammation with its known detrimental effect in the early phase following acute stroke. NET regulation therefore may be a potential target in stroke patients, especially to prevent secondary brain damage. The NET-STROKE study aims to characterize the role of NETs and their potential to serve as biomarkers in stroke patients. NET-STROKE is a single-center, prospective cohort study evaluating clinical, neuroimaging and blood NET-parameters in patients with ischemic and hemorrhagic stroke. We aim to identify if NETs correlate with clinical and imaging parameters (presence and volumes of infarction / hematoma / perifocal edema volume) and with functional outcome of stroke patients. Furthermore, we aim to identify specific profiles of NET-markers in stroke and in subgroups of patients, e.g., in those with hemorrhagic stroke. The NET-STROKE study is expected to contribute to characterize the mechanistic role of NETs in stroke. Given several potential NET treatments demonstrated in preclinical studies, NETs may serve as potential treatment targets in stroke patients to prevent secondary brain injury and functional impairment.

Health condition or problem studied

ICD10:
I61 - Intracerebral haemorrhage
ICD10:
I63 - Cerebral infarction
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Visits at day 1, 2, 6 and 90. For details see study protocol.

Endpoints

Primary outcome:
Not applicable (explorative) Descriptive: Functional Outcome at 3 months according to modified Rankin Scale (mRS) at 3 month
Secondary outcome:
not applicable

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Neurologie Augsburg

Recruitment period and number of participants

Planned study start date:
2023-01-10
Actual study start date:
2023-01-16
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
200
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
(1. Age >= years) 2. Clinical signs of ischemic or hemorrhagic (atraumatic) stroke with imaging correlates (CCT, MRI) 3. Time from symptom onset to admission at UKA < 24 hours 4. NIHSS score on admission >=1 5. Signed consent form

Exclusion Criteria

1. Acute disease within the last 4 weeks (intracranial hemorrhage, stroke, myocardial infarction, occlusion of peripheral arteries, venous thrombosis) 2. Active malignant disease 3. Active immune-mediate disease and / or immunosuppressive therapy 4. Palliative care established or planed

Addresses

Primary Sponsor

Universitätsklinikum Augsburg
Stenglinstr. 2
86156 Augsburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Neurologe, Universitätsklinikum Augsburg
PD Dr. med. Hauke Schneider
Stenglinstr. 2
86156 Augsburg
Germany
Telephone:
0821-4002854
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Neurologie, Universitätsklinikum Augsburg
PD Dr. med. Hauke Schneider
Stenglinstr. 2
86156 Augsburg
Germany
Telephone:
0821-4002854
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Neurologe, Universitätsklinikum Augsburg
PD Dr. med. Hauke Schneider
Stenglinstr. 2
86156 Augsburg
Germany
Telephone:
0821-4002854
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinik für Neurologie,Universitätsklinikum Augsburg
Stenglinstr. 2
86156 Augsburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Bayerischen Landesärztekammer
Mühlbaurstr. 16
81677 München
Germany
Telephone:
+49-89-4147165
Fax:
+49-89-4147334
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-10-10
Ethics committee number:
22098
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-12-15

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Anonymized data will be available on reasonable request.

Study protocol and other study documents

Study protocols:
NET-STROKE-Protokoll Version 1.1
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry