Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers

NCT02935985 | Completed

• 1 other identifier: 21288/ 04.10.2016
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Hemorrhage

Keywords

spontaneous intracerebral hemorrhage; point-of-care bio-markers; multicenter; Emergency Department; Romania

Outcome Measures

Primary Outcomes (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.

  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

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.

  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

  2 days from the enrollment

Study Arms (1)

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)

Interventions

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.

Adults with sICH less than 8h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (2)

Emergency Clinical County Hospital Cluj-Napoca - Emergency Department

Cluj-Napoca, Cluj, 400554, Romania

Location

Emergency Clinical County Hospital Cluj-Napoca - Neurology ward

Cluj-Napoca, Cluj, 400554, Romania

Location

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).

MeSH Terms

Conditions

Cerebral Hemorrhage; Emergencies

Interventions

C-Reactive Protein; fibrin fragment D; Blood Cell Count; Glucose; Cholesterol; Cholesterol, LDL; Triglycerides; Fibrinogen

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hexoses; Monosaccharides; Sugars; Carbohydrates; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids; Lipoproteins, LDL; Lipoproteins; Glycerides; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Eugenia M Muresan, MD, PhD stud

  Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: December 12, 2016
• Primary Completion: June 11, 2018
• Study Completion: November 24, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)