NCT02935985

Emergency Management of Spontaneous Intracerebral Haemorrhage - Biomarkers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cerebral Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-12
• Primary completion: 2018-06-11
• Completion: 2018-11-24
• First posted: 2016-10-18
• Last updated: 2019-07-23

Locations

2 sites across 1 country: Romania