Clinical Trial: Tranexamic Acid and Biomarkers in Emergency Management of Spontaneous Intracerebral Hemorrhage - Biomarkers Substudy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Tranexamic Acid and Biomarkers in Emergency Management of Spontaneous Intracerebral Hemorrhage - Biomarkers Substudy

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 Summary:

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).


Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Current Primary Outcome: 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. [ Time Frame: 180 days from the enrollment ]

Functional outcomes are defined as modified Rankin Score of 0 to 3 and Barthel Index of 60 to 100 points.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. [ Time Frame: 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 [ Time Frame: 2 days from the enrollment ]


Original Secondary Outcome: Same as current

Information By: Iuliu Hatieganu University of Medicine and Pharmacy

Dates:
Date Received: October 14, 2016
Date Started: December 2016
Date Completion: June 2019
Last Updated: May 10, 2017
Last Verified: May 2017