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Emergency Management of Spontaneous Intracerebral Hemorrhage - Biomarkers (EsICH)

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ClinicalTrials.gov Identifier: NCT02935985
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eugenia-Maria Muresan, Iuliu Hatieganu University of Medicine and Pharmacy

Brief 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 outcome of these patients and to determine their input for early risk stratification and prognosis.

Condition or disease Intervention/treatment
Cerebral Hemorrhage Other: Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)

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).


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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emergency Management of Spontaneous Intracerebral Hemorrhage - Biomarkers
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : June 11, 2018
Actual Study Completion Date : November 24, 2018


Group/Cohort Intervention/treatment
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.

Other: 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  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 edema surrounding the bleeding site [ Time Frame: 2 days from the enrollment ]

Biospecimen Retention:   Samples Without DNA

Venous blood samples will be collected from patients who have suffered a spontaneous intracerebral hemorrhage less than 8h ago.

Point-of-care bio-markers will be assessed by using an immunoanalyzer in the Emergency Department.

From the blood samples used for determining the other biological parameters (CBC, biochemistry, coagulogram).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients presenting in one of the study centers and having a diagnostic CT scan for intracerebral hemorrhage less than 8h old.
Criteria

Inclusion Criteria:

  1. Age over 18 years old
  2. CT scan diagnosis of an spontaneous intracerebral hemorrhage in the first 8h from the onset of the condition
  3. Informed consent
  4. Access to telephone evaluations (landline or mobile phone for the participant or a family member)

Exclusion Criteria:

  1. GCS < 8 points
  2. 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).
  3. Severe disability prior to this hemorrhagic event (modified Rankin Score =>4);
  4. Known venous thrombembolic condition
  5. History of coagulopathy (genetic or acquired)
  6. Recent ischemic events (< 12 months) (ischemic stroke, myocardial infarction, peripheric artheriopathy)
  7. History of seizures (or present condition)
  8. Undergoing treatment with heparin, LMWH, GPIIb/IIIa antagonists or oral anticoagulants (warfarin/ acenocumarol, factor Xa inhibitors, thrombin inhibitors - in the last 14 days)
  9. Pregnancy or breast feeding
  10. Scheduled neurosurgical intervention on the next 24h
  11. Ongoing of scheduled hemostatic treatment - prothrombin, vitamin K, fresh frozen plasma, platelets
  12. Enrollment in other clinical trials in the last 30 days
  13. Known terminal stage disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935985


Locations
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Romania
Emergency Clinical County Hospital Cluj-Napoca - Emergency Department
Cluj-Napoca, Cluj, Romania, 400554
Emergency Clinical County Hospital Cluj-Napoca - Neurology ward
Cluj-Napoca, Cluj, Romania, 400554
Sponsors and Collaborators
Iuliu Hatieganu University of Medicine and Pharmacy
Investigators
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Principal Investigator: Eugenia M Muresan, MD, PhD stud Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

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Responsible Party: Eugenia-Maria Muresan, Coordinating Investigator, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT02935985     History of Changes
Other Study ID Numbers: 21288/ 04.10.2016
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eugenia-Maria Muresan, Iuliu Hatieganu University of Medicine and Pharmacy:
spontaneous intracerebral hemorrhage
point-of-care bio-markers
multicenter
Emergency Department
Romania

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Intracranial Hemorrhages
Emergencies
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases