Prediction of Functional Recovery in Patients With Intracerebral Hemorrhage | NCT07728734

NCT07728734

Overview

NCT ID: NCT07728734
Lead Sponsor: Germans Trias i Pujol HospitalOTHER
Official Title: Early Prediction of Functional Recovery in Intracerebral Hemorrhage: Multicenter Validation of the PRO-ICH Scale (PROgnosis for Intracerebral Hemorrhage) and Its Refinement With New Prognostic Blood Biomarkers
Brief Summary: Currently, we lack sufficiently reliable tools to accurately predict, in the first few hours, the vital prognosis, functional status, and quality of life of patients with intracerebral hemorrhage (ICH). With new neurosurgical techniques and improvements in neurocritical care, it is essential to adapt therapeutic decisions to the wishes of patients and their families. Doing so based on a reliable functional prognosis will reduce arbitrariness in treatments and help avoid situations of unwanted dependency and high social and healthcare costs.

This project aims to validate, in several hospitals in Spain and in real-world clinical practice, a new, easy-to-implement predictive scale that estimates the probability of functional recovery in patients with ICH in the short and long term. It will also analyze new prognostic blood biomarkers that could enhance the scale's accuracy.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients ≥ 18 years diagnosed with spontaneous intracranial hemorrhage (ICH) by CT scan and treated maximally within the first 24 hours.

Prior functional independence defined as modified Rankin scale (mRS) ≤ 3.

Time from symptom onset or last known seen well ≤ 24 hours.

Signed informed consent by the patient or their representative.

Exclusion Criteria:

Age < 18 years

Intracranial hemorrhage secondary to trauma, ischemic stroke, or fibrinolytic or endovascular treatment.

Spontaneous ICH with limitation of therapeutic effort (LTE) within the first 24 hours. LTE is defined as the withholding or withdrawal of potentially life-sustaining treatment and/or the initiation of comfort care measures with the expectation that the patient may die as a result. Potentially life-sustaining treatments include: orotracheal intubation and mechanical ventilation, cardiopulmonary resuscitation, and neurosurgical treatments (intracranial pressure monitoring, external ventricular drainage, hematoma evacuation, decompressive craniectomy). LTE is not considered to apply if only a do-not-resuscitate (DNR) order was established, without limitation of any other treatment.

Prior functional dependence, defined as mRS > 3

Time from symptom onset or last known seen well >24 hours