Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers

Cerebral Hemorrhage Clinical Trial

— EsICH  

Official title:

Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935985
• Other study ID #: 21288/ 04.10.2016
• Status: Completed
• Start date: December 12, 2016
• Est. completion date: November 24, 2018

Study information

• Verified date: July 2019
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 24, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Emergencies
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Romania	Emergency Clinical County Hospital Cluj-Napoca - Emergency Department	Cluj-Napoca	Cluj
Romania	Emergency Clinical County Hospital Cluj-Napoca - Neurology ward	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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