Delayed Cerebral Ischemia After Subarachnoid HemorrhageNCT07354321
Thrombo-inflammation in Acute Neurovascular Diseases: Definition of New Therapeutic Targets (TARGETS)
An observational study of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage and Ischemic Stroke of Large or Medium Vessels, run by François Delvoye.
Trial summary
The objective of this observational study is to compare the relative concentrations of various thrombo-inflammatory markers at different follow-up time points in: patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, and patients with or without rapid progression of necrotic volume after an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delayed Cerebral Ischemia After Subarachnoid Hemorrhage, Ischemic Stroke of Large or Medium Vessels
- How many people
- 499 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Among patients treated at Liège University Hospital.
Who may be able to join
- Patients aged 18 years or older
- Admitted within 8 hours of an acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) or medium-vessel occlusion (MeVO) of the anterior circulation, with a NIHSS (National Institutes of Health Stroke Scale) score > 5 (M1, M2, M3, A1, A2, A3, P1, P2)
- Or admitted within 36 hours of acute symptoms related to aneurysmal subarachnoid hemorrhage (SAH)
Who cannot join
- Patients with pre-existing functional and/or cognitive disability (modified Rankin Scale, mRS > 1)
- Patients under legal protection or guardianship
- Patients with secondary hemorrhagic transformation of an acute ischemic stroke
- Patients with acute ischemic stroke and NIHSS > 5 without LVO or MeVO of the anterior circulation on imaging will be secondarily excluded. Perfusion imaging will not be performed as part of the research protocol. Excluded patients will be replaced.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thrombo-inflammation Des Maladies Neurovascualires aiguës : définition de Nouvelles Cibles thérapeutiques (TARGETS)
The objective of this observational study is to compare the relative concentrations of various thrombo-inflammatory markers at different follow-up time points in:
- patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, and
- patients with or without rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation.
Read more
The main question this study aims to answer is: How do thrombo-inflammatory marker concentrations evolve over time and differ between patients? Researchers will compare patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, as well as patients with or without rapid progression of necrotic volume following an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation, to determine whether there are differences in thrombo-inflammatory marker concentrations and in their evolution over time.
Participants will undergo blood sampling at five different time points. In addition, participants will complete a Montreal Cognitive Assessment (MoCA) questionnaire during the 3-month follow-up visit.
- Conditions
- Delayed Cerebral Ischemia After Subarachnoid Hemorrhage, Ischemic Stroke of Large or Medium Vessels
- Keywords
- delayed cerebral ischemia, subarachnoid hemorrhage, ischemic stroke
- Medical subject headings
- Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AIC | Patient with rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation | |
| HSA | Patient with delayed cerebral ischemia after subarachnoid hemorrhage | |
| healthy volunteer | healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
Measured: From enrollment to Month 3 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Delayed Cerebral Ischemia After Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 499 participants (estimated)
Sponsor and investigators
- Lead sponsor
- François Delvoye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, François Delvoye, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354321
- Sponsor's protocol ID
- B7072025000062
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Accessible upon request after publication
Publications
Ray B, Ross SR, Danala G, Aghaei F, Nouh CD, Ford L, Hollabaugh KM, Karfonta BN, Santucci JA, Cornwell BO, Bohnstedt BN, Zheng B, Dale GL, Prodan CI. Systemic response of coated-platelet and peripheral blood inflammatory cell indices after aneurysmal subarachnoid hemorrhage and long-term clinical outcome. J Crit Care. 2019 Aug;52:1-9. doi: 10.1016/j.jcrc.2019.03.003. Epub 2019 Mar 14.
PubMed 30904732Tso MK, Macdonald RL. Acute microvascular changes after subarachnoid hemorrhage and transient global cerebral ischemia. Stroke Res Treat. 2013;2013:425281. doi: 10.1155/2013/425281. Epub 2013 Mar 25.
PubMed 23589781Friedrich V, Flores R, Muller A, Sehba FA. Luminal platelet aggregates in functional deficits in parenchymal vessels after subarachnoid hemorrhage. Brain Res. 2010 Oct 1;1354:179-87. doi: 10.1016/j.brainres.2010.07.040. Epub 2010 Jul 21.
PubMed 20654597Dankbaar JW, Rijsdijk M, van der Schaaf IC, Velthuis BK, Wermer MJ, Rinkel GJ. Relationship between vasospasm, cerebral perfusion, and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Neuroradiology. 2009 Dec;51(12):813-9. doi: 10.1007/s00234-009-0575-y. Epub 2009 Jul 22.
PubMed 19623472Park SW, Lee JY, Heo NH, Han JJ, Lee EC, Hong DY, Lee DH, Lee MR, Oh JS. Short- and long-term mortality of subarachnoid hemorrhage according to hospital volume and severity using a nationwide multicenter registry study. Front Neurol. 2022 Aug 5;13:952794. doi: 10.3389/fneur.2022.952794. eCollection 2022.
PubMed 35989903Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17.
PubMed 37197995Naraoka M, Matsuda N, Shimamura N, Ohkuma H. Role of microcirculatory impairment in delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2022 Jan;42(1):186-196. doi: 10.1177/0271678X211045446. Epub 2021 Sep 9.
PubMed 34496662Frontera JA, Provencio JJ, Sehba FA, McIntyre TM, Nowacki AS, Gordon E, Weimer JM, Aledort L. The Role of Platelet Activation and Inflammation in Early Brain Injury Following Subarachnoid Hemorrhage. Neurocrit Care. 2017 Feb;26(1):48-57. doi: 10.1007/s12028-016-0292-4.
PubMed 27430874Zhou P, Li T, Jin J, Liu Y, Li B, Sun Q, Tian J, Zhao H, Liu Z, Ma S, Zhang S, Novakovic VA, Shi J, Hu S. Interactions between neutrophil extracellular traps and activated platelets enhance procoagulant activity in acute stroke patients with ICA occlusion. EBioMedicine. 2020 Mar;53:102671. doi: 10.1016/j.ebiom.2020.102671. Epub 2020 Feb 27.
PubMed 32114386Coulibaly AP, Pezuk P, Varghese P, Gartman W, Triebwasser D, Kulas JA, Liu L, Syed M, Tvrdik P, Ferris H, Provencio JJ. Neutrophil Enzyme Myeloperoxidase Modulates Neuronal Response in a Model of Subarachnoid Hemorrhage by Venous Injury. Stroke. 2021 Oct;52(10):3374-3384. doi: 10.1161/STROKEAHA.120.033513. Epub 2021 Aug 18.
PubMed 34404234Ishikawa M, Kajimura M, Morikawa T, Tsukada K, Tsuji T, Kusaka G, Tanaka Y, Suematsu M. Leukocyte plugging and cortical capillary flow after subarachnoid hemorrhage. Acta Neurochir (Wien). 2016 Jun;158(6):1057-67. doi: 10.1007/s00701-016-2792-6. Epub 2016 Apr 4.
PubMed 27040552Ishikawa M, Kusaka G, Yamaguchi N, Sekizuka E, Nakadate H, Minamitani H, Shinoda S, Watanabe E. Platelet and leukocyte adhesion in the microvasculature at the cerebral surface immediately after subarachnoid hemorrhage. Neurosurgery. 2009 Mar;64(3):546-53; discussion 553-4. doi: 10.1227/01.NEU.0000337579.05110.F4.
PubMed 19240618Sehba FA, Mostafa G, Friedrich V Jr, Bederson JB. Acute microvascular platelet aggregation after subarachnoid hemorrhage. J Neurosurg. 2005 Jun;102(6):1094-100. doi: 10.3171/jns.2005.102.6.1094.
PubMed 16028769Chen Y, Galea I, Macdonald RL, Wong GKC, Zhang JH. Rethinking the initial changes in subarachnoid haemorrhage: Focusing on real-time metabolism during early brain injury. EBioMedicine. 2022 Sep;83:104223. doi: 10.1016/j.ebiom.2022.104223. Epub 2022 Aug 13.
PubMed 35973388Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
PubMed 37212182
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombo-inflammation Des Maladies Neurovascualires aiguës : définition de Nouvelles Cibles thérapeutiques (TARGETS)
- ClinicalTrials.gov ID
- NCT07354321
- Acronym / sponsor ID
- B7072025000062
- Conditions
- Delayed Cerebral Ischemia After Subarachnoid Hemorrhage, Ischemic Stroke of Large or Medium Vessels
- Keywords
- delayed cerebral ischemia, subarachnoid hemorrhage, ischemic stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 499 participants (estimated)
- Lead sponsor
- François DelvoyeUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this observational study is to compare the relative concentrations of various thrombo-inflammatory markers at different follow-up time points in:
- patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, and
- patients with or without rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation.
The main question this study aims to answer is: How do thrombo-inflammatory marker concentrations evolve over time and differ between patients? Researchers will compare patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, as well as patients with or without rapid progression of necrotic volume following an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation, to determine whether there are differences in thrombo-inflammatory marker concentrations and in their evolution over time.
Participants will undergo blood sampling at five different time points. In addition, participants will complete a Montreal Cognitive Assessment (MoCA) questionnaire during the 3-month follow-up visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIC | – | –Patient with rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation |
| HSA | – | –Patient with delayed cerebral ischemia after subarachnoid hemorrhage |
| healthy volunteer | – | –healthy volunteer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Among patients treated at Liège University Hospital.
Key inclusion criteria (3 listed)
- Patients aged 18 years or older
- Admitted within 8 hours of an acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) or medium-vessel occlusion (MeVO) of the anterior circulation, with a NIHSS (National Institutes of Health Stroke Scale) score > 5 (M1, M2, M3, A1, A2, A3, P1, P2)
- Or admitted within 36 hours of acute symptoms related to aneurysmal subarachnoid hemorrhage (SAH)
Key exclusion criteria (4 listed)
- Patients with pre-existing functional and/or cognitive disability (modified Rankin Scale, mRS > 1)
- Patients under legal protection or guardianship
- Patients with secondary hemorrhagic transformation of an acute ischemic stroke
- Patients with acute ischemic stroke and NIHSS > 5 without LVO or MeVO of the anterior circulation on imaging will be secondarily excluded. Perfusion imaging will not be performed as part of the research protocol. Excluded patients will be replaced.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
Time frame: From enrollment to Month 3 visit
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 30904732Ray B, Ross SR, Danala G, Aghaei F, Nouh CD, Ford L, Hollabaugh KM, Karfonta BN, Santucci JA, Cornwell BO, Bohnstedt BN, Zheng B, Dale GL, Prodan CI. Systemic response of coated-platelet and peripheral blood inflammatory cell indices after aneurysmal subarachnoid hemorrhage and long-term clinical outcome. J Crit Care. 2019 Aug;52:1-9. doi: 10.1016/j.jcrc.2019.03.003. Epub 2019 Mar 14.
- Background: PubMed 23589781Tso MK, Macdonald RL. Acute microvascular changes after subarachnoid hemorrhage and transient global cerebral ischemia. Stroke Res Treat. 2013;2013:425281. doi: 10.1155/2013/425281. Epub 2013 Mar 25.
- Background: PubMed 20654597Friedrich V, Flores R, Muller A, Sehba FA. Luminal platelet aggregates in functional deficits in parenchymal vessels after subarachnoid hemorrhage. Brain Res. 2010 Oct 1;1354:179-87. doi: 10.1016/j.brainres.2010.07.040. Epub 2010 Jul 21.
- Background: PubMed 19623472Dankbaar JW, Rijsdijk M, van der Schaaf IC, Velthuis BK, Wermer MJ, Rinkel GJ. Relationship between vasospasm, cerebral perfusion, and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Neuroradiology. 2009 Dec;51(12):813-9. doi: 10.1007/s00234-009-0575-y. Epub 2009 Jul 22.
- Background: PubMed 35989903Park SW, Lee JY, Heo NH, Han JJ, Lee EC, Hong DY, Lee DH, Lee MR, Oh JS. Short- and long-term mortality of subarachnoid hemorrhage according to hospital volume and severity using a nationwide multicenter registry study. Front Neurol. 2022 Aug 5;13:952794. doi: 10.3389/fneur.2022.952794. eCollection 2022.
- Background: PubMed 37197995Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17.
- Background: PubMed 34496662Naraoka M, Matsuda N, Shimamura N, Ohkuma H. Role of microcirculatory impairment in delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2022 Jan;42(1):186-196. doi: 10.1177/0271678X211045446. Epub 2021 Sep 9.
- Background: PubMed 27430874Frontera JA, Provencio JJ, Sehba FA, McIntyre TM, Nowacki AS, Gordon E, Weimer JM, Aledort L. The Role of Platelet Activation and Inflammation in Early Brain Injury Following Subarachnoid Hemorrhage. Neurocrit Care. 2017 Feb;26(1):48-57. doi: 10.1007/s12028-016-0292-4.
- Background: PubMed 32114386Zhou P, Li T, Jin J, Liu Y, Li B, Sun Q, Tian J, Zhao H, Liu Z, Ma S, Zhang S, Novakovic VA, Shi J, Hu S. Interactions between neutrophil extracellular traps and activated platelets enhance procoagulant activity in acute stroke patients with ICA occlusion. EBioMedicine. 2020 Mar;53:102671. doi: 10.1016/j.ebiom.2020.102671. Epub 2020 Feb 27.
- Background: PubMed 34404234Coulibaly AP, Pezuk P, Varghese P, Gartman W, Triebwasser D, Kulas JA, Liu L, Syed M, Tvrdik P, Ferris H, Provencio JJ. Neutrophil Enzyme Myeloperoxidase Modulates Neuronal Response in a Model of Subarachnoid Hemorrhage by Venous Injury. Stroke. 2021 Oct;52(10):3374-3384. doi: 10.1161/STROKEAHA.120.033513. Epub 2021 Aug 18.
- Background: PubMed 27040552Ishikawa M, Kajimura M, Morikawa T, Tsukada K, Tsuji T, Kusaka G, Tanaka Y, Suematsu M. Leukocyte plugging and cortical capillary flow after subarachnoid hemorrhage. Acta Neurochir (Wien). 2016 Jun;158(6):1057-67. doi: 10.1007/s00701-016-2792-6. Epub 2016 Apr 4.
- Background: PubMed 19240618Ishikawa M, Kusaka G, Yamaguchi N, Sekizuka E, Nakadate H, Minamitani H, Shinoda S, Watanabe E. Platelet and leukocyte adhesion in the microvasculature at the cerebral surface immediately after subarachnoid hemorrhage. Neurosurgery. 2009 Mar;64(3):546-53; discussion 553-4. doi: 10.1227/01.NEU.0000337579.05110.F4.
- Individual participant dataSharing planned: Undecided. Accessible upon request after publication
Related trials for Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months
Ruptured Aneurysm of Intracranial Artery, SAH (Subarachnoid Hemorrhage)
RecruitingObservational study
Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension
Subarachnoid Aneurysm Hemorrhage, Cerebral Vasospasm After Subarachnoid Hemorrhage
Not yet recruiting
Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage (aSAH)
RecruitingObservational study
Investigation of the Role of Inflammatory Markers in the Early Detection of Cerebral Vasospasm, Delayed Cerebral Ischemia, and Meningitis Associated With External Cerebrospinal Fluid Drainage After Non-Traumatic Subarachnoid Hemorrhage - A Prospective Case-Control Study
Subarachnoid Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage and Ischemic Stroke of Large or Medium Vessels, run by François Delvoye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Delvoye, MD, PhD (04/3236630, fdelvoye@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time. (time frame: From enrollment to Month 3 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354321, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.