Cerebral HemorrhageEsICHNCT02935985
Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers
An observational study of Cerebral Hemorrhage, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
Trial summary
The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h) spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)
- How many people
- 39 participants
- Where
- 2 sitesRomania
- Study dates
- 12 Dec 2016to 24 Nov 2018
- 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: Adult patients presenting in one of the study centers and having a diagnostic CT scan for intracerebral hemorrhage less than 8h old.
Who may be able to join
- Age over 18 years old
- CT scan diagnosis of an spontaneous intracerebral hemorrhage in the first 8h from the onset of the condition
- Informed consent
- Access to telephone evaluations (landline or mobile phone for the participant or a family member)
Who cannot join
- GCS < 8 points
- Secondary cause of the intracerebral hemorrhage (trauma, known AVM, aneurysm, hemorrhagic transformation of an ischemic stroke, thrombosis of central veins and sinuses, thrombolitic therapy, tumors, infections).
- Severe disability prior to this hemorrhagic event (modified Rankin Score =>4);
- Known venous thrombembolic condition
- History of coagulopathy (genetic or acquired)
- Recent ischemic events (< 12 months) (ischemic stroke, myocardial infarction, peripheric artheriopathy)
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- History of seizures (or present condition)
- Undergoing treatment with heparin, LMWH, GPIIb/IIIa antagonists or oral anticoagulants (warfarin/ acenocumarol, factor Xa inhibitors, thrombin inhibitors - in the last 14 days)
- Pregnancy or breast feeding
- Scheduled neurosurgical intervention on the next 24h
- Ongoing of scheduled hemostatic treatment - prothrombin, vitamin K, fresh frozen plasma, platelets
- Enrollment in other clinical trials in the last 30 days
- Known terminal stage disease
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Emergency Clinical County Hospital Cluj-Napoca - Emergency Department
Cluj-Napoca, Cluj, 400554
Emergency Clinical County Hospital Cluj-Napoca - Neurology ward
Cluj-Napoca, Cluj, 400554
About this study
The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h) spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
Read the detailed description
EsICH is designed as a multicenter double blind randomized (2:1) clinical trial assessing the effects of tranexamic acid (2g in total) on patients with acute (first 8h) spontaneous intracerebral hemorrhage.
The bio-markers substudy addresses the same category of patients and assesses biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
The patients with a diagnostic CT scan are recruited in the Emergency Departments or Neurology/ Neurosurgery Wards of the hospitals enrolled in the study and blood samples are drawn in the first 8h from the onset of the condition. The patient is then clinically assessed by the study investigators for the first 7 days of the admission and a second CT scan is performed on the second day (24h from the onset of the condition).
Telephone follow-ups will be completed on day 90 and 180 by the coordinating center of the study.
The bio-markers substudy is an observational, prospective multicenter (the study will be initially started in one center - Cluj-Napoca - and then the Tirgu Mures center will be activated. Two more centers might be also included on a later time - Alba and Bistrita-Nasaud, pending on financial and logistic reasons).
- Conditions
- Cerebral Hemorrhage
- Being tested
- Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)
- Keywords
- spontaneous intracerebral hemorrhage, point-of-care bio-markers, multicenter, Emergency Department, Romania
- Medical subject headings
- Cerebral Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)Other
Clinical evaluations will be performed, along with collecting venous blood samples for determining point-of-care bio-markers and biological parameters.
Participants will be assessed (clinically or by telephone) over a period of 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Adults with sICH less than 8h | Adult patients presenting in one of the study locations and being diagnosed with intracerebral hemorrhage. The onset of the conditions is establised as sonner than 8h.
Clinical evaluations will be performed, along with collecting venous blood samples for determining point-of-care bio-markers and biological parameters.
Participants will be assessed (clinically or by telephone) over a period of 180 days. Receives: Other: Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the functional recovery of SICH patients on day 180.
Functional outcomes are defined as modified Rankin Score of 0 to 3 and Barthel Index of 60 to 100 points.
Measured: 180 days from the enrollment
Secondary outcomes (2)
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the hematoma volume.
Measured: 2 days from the enrollment
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the edema surrounding the bleeding site
Measured: 2 days from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start12 Dec 2016
- Primary completion11 Jun 2018
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenia-Maria Muresan, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Eugenia M Muresan, MD, PhD stud, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935985
- Sponsor's protocol ID
- 21288/ 04.10.2016
- Acronym
- EsICH
- Status last verified
- Jul 2019
- First submitted
- 14 Oct 2016
- Last updated
- 23 Jul 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers
- ClinicalTrials.gov ID
- NCT02935985
- Acronym / sponsor ID
- EsICH / 21288/ 04.10.2016
- Conditions
- Cerebral Hemorrhage
- Keywords
- spontaneous intracerebral hemorrhage, point-of-care bio-markers, multicenter, Emergency Department, Romania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 18 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.
The bio-markers substudy of EsICH is designed to recruit patients with acute (first 8h) spontaneous intracerebral hemorrhage and assess a series of biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
Detailed description
EsICH is designed as a multicenter double blind randomized (2:1) clinical trial assessing the effects of tranexamic acid (2g in total) on patients with acute (first 8h) spontaneous intracerebral hemorrhage.
The bio-markers substudy addresses the same category of patients and assesses biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides) and point-of-care bio-markers (cTnI, hsCRP, D-Dimer) in order to predict the functional outcome of these patients and to determine their input for early risk stratification and prognosis.
The patients with a diagnostic CT scan are recruited in the Emergency Departments or Neurology/ Neurosurgery Wards of the hospitals enrolled in the study and blood samples are drawn in the first 8h from the onset of the condition. The patient is then clinically assessed by the study investigators for the first 7 days of the admission and a second CT scan is performed on the second day (24h from the onset of the condition).
Telephone follow-ups will be completed on day 90 and 180 by the coordinating center of the study.
The bio-markers substudy is an observational, prospective multicenter (the study will be initially started in one center - Cluj-Napoca - and then the Tirgu Mures center will be activated. Two more centers might be also included on a later time - Alba and Bistrita-Nasaud, pending on financial and logistic reasons).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with sICH less than 8h | – | Other: Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)Adult patients presenting in one of the study locations and being diagnosed with intracerebral hemorrhage. The onset of the conditions is establised as sonner than 8h. Clinical evaluations will be performed, along with collecting venous blood samples for determining point-of-care bio-markers and biological parameters. Participants will be assessed (clinically or by telephone) over a period of 180 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting in one of the study centers and having a diagnostic CT scan for intracerebral hemorrhage less than 8h old.
Key inclusion criteria (4 listed)
- Age over 18 years old
- CT scan diagnosis of an spontaneous intracerebral hemorrhage in the first 8h from the onset of the condition
- Informed consent
- Access to telephone evaluations (landline or mobile phone for the participant or a family member)
Key exclusion criteria (13 listed)
- GCS < 8 points
- Secondary cause of the intracerebral hemorrhage (trauma, known AVM, aneurysm, hemorrhagic transformation of an ischemic stroke, thrombosis of central veins and sinuses, thrombolitic therapy, tumors, infections).
- Severe disability prior to this hemorrhagic event (modified Rankin Score =>4);
- Known venous thrombembolic condition
- History of coagulopathy (genetic or acquired)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)Clinical evaluations will be performed, along with collecting venous blood samples for determining point-of-care bio-markers and biological parameters. Participants will be assessed (clinically or by telephone) over a period of 180 days. | Other | Adults with sICH less than 8h |
Primary outcome
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the functional recovery of SICH patients on day 180.
Time frame: 180 days from the enrollment
Functional outcomes are defined as modified Rankin Score of 0 to 3 and Barthel Index of 60 to 100 points.
2 secondary outcomes
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the hematoma volume.
Time frame: 2 days from the enrollment
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the edema surrounding the bleeding site
Time frame: 2 days from the enrollment
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 23 Jul 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.
Eugenia M Muresan, MD, PhD stud principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage, run by Iuliu Hatieganu University of Medicine and Pharmacy at 2 sites in Romania.
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 4 inclusion and 13 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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?
Assessment of the correlation between point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen) and the functional recovery of SICH patients on day 180. (time frame: 180 days from the enrollment). 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 23 Jul 2019.