- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476188
Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke (NETs)
Study Overview
Detailed Description
Neutrophil extracellular traps (NETs) were measured in serum at the time of hospitalization, then at 4 hours, 24 hours and 72 hours after stroke. Because of nucleosome instability, a strict preanalytical protocol was followed. Blood samples were centrifuged within 1-2 h after blood drawing. A strict preanalytical protocol was followed including early centrifugation of the samples and storage at - 80°C. NETs were quantified in batches containing all samples from a patient using the detection of MPO (myeloperoxidase) then the Cell-Death-Detection ELISAPLUS (Roche Diagnostics, Germany) as described earlier. Nucleosomes were quantified in relative arbitrary units (AU). Blood samples from each patient were measured within the same run to improve the comparability of the results.
For statistical analysis, various variables of nucleosomes were considered, such as the absolute concentrations determined at admission, at 24 hours and at 72 hours after stroke. Influence of nucleosome concentration on recanalization was tested. Continuous correlations of nucleosomes and infarction volume, nucleosomes and clot size, as well as of infarction volume and NIHSS were calculated by Spearman's rank correlation together with the 95% confidence interval. A p value < 0.05 was considered statistically significant.
The extent of the morphological damage was determined at time of admission to the hospital and 24 hours after thrombolysis by diffusion-weighted magnetic resonance imaging (MRI). The pretreat¬ment and follow-up DWI lesions was segmented using interactive tools based on DWI signal intensity thresholding within a 3-dimensional mask encompassing the apparent area of bright DWI signal intensity and morphometric filtering. The clot location and length were assessed on the susceptibility vessel sign on T2* as describe earlier.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Centre Hospitalier Sainte-Anne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ("Patients" + "Patients control" groups) :
Inclusion-1st sample of blood : every patient recruited within the neurovascular unit of intensive care of the Hospital center Sainte - Anne within the framework of a "thrombolyse alert ".
Then pursuit of the study ("patients" group only) if :
- Age 18 minimum
- Sylvien Infarct proved by the intellectual MRI,
- Whatever is the treatment received (Aspegic, thombolysis and/or thrombectomy)
- That there is occlusion of a cerebral artery or not "Controls" group :
- Healthy subjects,
- Mated on the age and the vascular risk factors (tobacco, arterial high blood pressure, diabetes and dyslipidémie)
Exclusion Criteria:
- Patients:
Contraindications in the intravenous thrombolysis according to the current recommendations .
- Controls:
- Histories of evolutionary pathology or thrombo-embolique, taken by treatment whatever it is except contraceptive for the women, the viral or bacterial infection in the month precedents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
Samples of blood at H0, H+6, H+24 and H+72
|
|
Experimental: Patients control
Samples of blood at H0
|
|
Active Comparator: Control (healthy person)
Samples of blood at H0
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recanalisation
Time Frame: 24 hours
|
Correlation between NETs and stroke severity
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombus size on MRI
Time Frame: 24 hours
|
Correlation between NETs and stroke severity
|
24 hours
|
Stroke volume on MRI
Time Frame: 24 hours
|
Correlation between NETs and stroke severity
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Michel PLOTKINE, PhD, University of Paris 5 - Rene Descartes
Publications and helpful links
General Publications
- Holdenrieder S, Stieber P, Bodenmuller H, Fertig G, Furst H, Schmeller N, Untch M, Seidel D. Nucleosomes in serum as a marker for cell death. Clin Chem Lab Med. 2001 Jul;39(7):596-605. doi: 10.1515/CCLM.2001.095.
- Holdenrieder S, Stieber P, Chan LY, Geiger S, Kremer A, Nagel D, Lo YM. Cell-free DNA in serum and plasma: comparison of ELISA and quantitative PCR. Clin Chem. 2005 Aug;51(8):1544-6. doi: 10.1373/clinchem.2005.049320. No abstract available.
- Naggara O, Raymond J, Domingo Ayllon M, Al-Shareef F, Touze E, Chenoufi M, Gerber S, Mellerio C, Zuber M, Meder JF, Mas JL, Oppenheim C. T2* "susceptibility vessel sign" demonstrates clot location and length in acute ischemic stroke. PLoS One. 2013 Oct 11;8(10):e76727. doi: 10.1371/journal.pone.0076727. eCollection 2013.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D15-P007
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.
Clinical Trials on Acute Stroke
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Centre hospitalier de l'Université de Montréal...Not yet recruitingStroke, Acute ThromboticCanada
-
University of MiamiTemporarily not availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
Dongzhimen Hospital, BeijingThe Second Hospital of Hebei Medical University; Peking University Third Hospital and other collaboratorsRecruitingStroke, Ischemic | Stroke, Acute | Acute Ischemic StrokeChina
-
University Hospital, MontpellierNot yet recruiting
-
Capital Medical UniversityRecruitingAcute Stroke | Ischemic Stroke, AcuteChina
-
Chonbuk National University HospitalKorean Society of Neurosonology; Ministry of SMEs and Startups, Republic of... and other collaboratorsCompleted
-
National Taiwan University HospitalCompleted
-
University of EdinburghNHS LothianRecruiting
Clinical Trials on Sample of Blood
-
Centre Hospitalier Universitaire DijonCompletedAssisted Reproductive Technology | Freezing/Thawing Procedure | Prolonged Culture ProcedureFrance
-
Dana-Farber Cancer InstituteStand Up To CancerRecruitingMultiple MyelomaUnited States
-
Medical University of WarsawCompletedArthroplasty | Platelet Aggregation | Methylmethacrylate EmbolismPoland
-
IgenomixRecruitingLeiomyoma, Uterine | Leiomyosarcoma UterusSpain
-
Centre Hospitalier Universitaire DijonCompleted
-
Memorial Sloan Kettering Cancer CenterActive, not recruiting
-
Meir Medical CenterCompleted
-
Medical University of WarsawCompletedFemoral Neck Fractures | Bone Loss | Bone Resorption | Muscle Loss | Muscle Damage | Pertrochanteric FracturePoland
-
University of Kansas Medical CenterCompletedGraft Versus Host Disease | Blood Stem Cell Transplant FailureUnited States
-
University Hospital, AngersRecruitingFebrile Neutropenia | Cancer ChildhoodFrance