Cerebral InfarctTHINKNCT02948465
Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia
An observational study of Cerebral Infarct, run by Hopital Foch at 1 site in France.
Trial summary
Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarct
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2016to 10 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Cerebral infact after wide calibre arterial occlusion
Who may be able to join
- Patient over 18
- Having a cerebral infarct consecutive to a wide calibre arterial occlusion
- taken care for mechanical thrombectomy
Who cannot join
- Patient benefiting from a legal protective measure
- Pregnant or breast-feeding woman
- Opposition of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.
The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).
- Conditions
- Cerebral Infarct
- Keywords
- Neutrophil Extracellular Traps
- Medical subject headings
- Cerebral Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start22 Jul 2016
- Primary completion10 Dec 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo CONSOLI, MD, Principal investigator, Hopital FochBertrand LAPERGUE, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948465
- Sponsor's protocol ID
- 2016/37
- Acronym
- THINK
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT02948465
- Acronym / sponsor ID
- THINK / 2016/37
- Conditions
- Cerebral Infarct
- Keywords
- Neutrophil Extracellular Traps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.
The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cerebral infact after wide calibre arterial occlusion
Key inclusion criteria (3 listed)
- Patient over 18
- Having a cerebral infarct consecutive to a wide calibre arterial occlusion
- taken care for mechanical thrombectomy
Key exclusion criteria (3 listed)
- Patient benefiting from a legal protective measure
- Pregnant or breast-feeding woman
- Opposition of the patient to participate in the study
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
Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Arturo CONSOLI, MD principal investigator
Hopital Foch
Bertrand LAPERGUE, MD study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarct, run by Hopital Foch at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2019.