Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers (EsICH)

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Hemorrhage
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400554
      • Emergency Clinical County Hospital Cluj-Napoca - Emergency Department
    • Cluj-Napoca, Cluj, Romania, 400554
      • Emergency Clinical County Hospital Cluj-Napoca - Neurology ward

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	2 days from the enrollment

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Eugenia M Muresan, MD, PhD stud, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): November 24, 2018

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Emergency Department; multicenter; spontaneous intracerebral hemorrhage; Romania; point-of-care bio-markers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Intracranial Hemorrhages; Emergencies; Hemorrhage; Cerebral Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: 21288/ 04.10.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO