Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days from the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients presenting in one of the study centers and having a diagnostic CT scan for intracerebral hemorrhage less than 8h old.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eugenia M Muresan, MD, PhD stud | Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Clinical County Hospital Cluj-Napoca - Emergency Department | Cluj-Napoca | Cluj | 400554 | Romania | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
|
| 2 days from the enrollment |
| Emergency Clinical County Hospital Cluj-Napoca - Neurology ward |
| Cluj-Napoca |
| Cluj |
| 400554 |
| Romania |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002097 | C-Reactive Protein |
| C036309 | fibrin fragment D |
| D001772 | Blood Cell Count |
| D005947 | Glucose |
| D002784 | Cholesterol |
| D008078 | Cholesterol, LDL |
| D014280 | Triglycerides |
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D007162 | Immunoproteins |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D008077 | Lipoproteins, LDL |
| D008074 | Lipoproteins |
| D005989 | Glycerides |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided