Clinical trial NCT02935985: Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers
Official title: Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Hemorrhage
Keywords: spontaneous intracerebral hemorrhage
point-of-care bio-markers
multicenter
Emergency Department
Romania
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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

Primary outcomes:
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.
timeFrame: 180 days from the enrollment
Secondary outcomes:
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 hematoma volume.
timeFrame: 2 days from the enrollment
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 edema surrounding the bleeding site
timeFrame: 2 days from the enrollment
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Emergency Clinical County Hospital Cluj-Napoca - Emergency Department
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Emergency Clinical County Hospital Cluj-Napoca - Neurology ward
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
name: Eugenia M Muresan, MD, PhD stud
role: PRINCIPAL_INVESTIGATOR
References: