Stroke, AcuteHEMOLYSENCT02893631
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
An observational study of Stroke, Acute, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 21 Dec 2017
- 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: rtPA-treated patients requiring endovascular treatment for ischemic stroke
Who may be able to join
- patient over 18
- treatment with rtPA for an acute stroke
- endovascular treatment required
Who cannot join
- opposition to participate in the study
- long term anticoagulant-treated patient
- pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue.
Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders.
Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrinolysis activity
Time required for normalization of fibrinolysis
Measured: until normalization of fibrinolytic activity, up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2015
- Primary completion21 Nov 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marie-Claire NGHE, MD, PhD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893631
- Sponsor's protocol ID
- AGR_2015_25
- Acronym
- HEMOLYSE
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02893631
- Acronym / sponsor ID
- HEMOLYSE / AGR_2015_25
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Sep 2015 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 8 Sep 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.
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue.
Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders.
Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- rtPA-treated patients requiring endovascular treatment for ischemic stroke
Key inclusion criteria (3 listed)
- patient over 18
- treatment with rtPA for an acute stroke
- endovascular treatment required
Key exclusion criteria (3 listed)
- opposition to participate in the study
- long term anticoagulant-treated patient
- pregnant patient
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
fibrinolysis activity
Time frame: until normalization of fibrinolytic activity, up to 48 hours
Time required for normalization of fibrinolysis
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 19 Oct 2020.
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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.
Marie-Claire NGHE, MD, PhD principal investigator
Fondation OPH A de Rothschild
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 Stroke, Acute, run by Fondation Ophtalmologique Adolphe de Rothschild 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 19 Oct 2020. 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?
fibrinolysis activity (time frame: until normalization of fibrinolytic activity, up to 48 hours). 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 19 Oct 2020.