Prediction of Functional Recovery in Patients With Intracerebral Hemorrhage

NCT07728734 · tracked via the Priya Life Science Spain tracker

Sponsor

Germans Trias i Pujol Hospital

Phase

Observational

Started

2026-07-01

Last updated

2026-07-28

Condition(s) studied

Intracranial Hemorrhage, Spontaneous

Investigational drug(s) / intervention(s)

CLINICAL SCORE TO PREDICT FUNCTIONAL OUTCOMEVariables necessary for calculating the score under study (PRO-ICH) will be collected, as well as baseline and 60-120 minutes after baseline of serum blood samples

CLINICAL SCORE TO PREDICT FUNCTIONAL OUTCOME: No other interventions

Variables necessary for calculating the score under study (PRO-ICH) will be collected, as well as baseline and 60-120 minutes after baseline of serum blood samples: No other interventions

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients ≥ 18 years diagnosed with spontaneous intracranial hemorrhage (ICH) by CT scan and treated maximally within the first 24 hours. 2. Prior functional independence defined as modified Rankin scale (mRS) ≤ 3. 3. Time from symptom onset or last known seen well ≤ 24 hours. 4. Signed informed consent by the patient or their representative. Exclusion Criteria: 1. Age \< 18 years 2. Intracranial hemorrhage secondary to trauma, ischemic stroke, or fibrinolytic or endovascular treatment. 3. 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. 4. Prior functional dependence, defined as mRS \> 3 5. Time from symptom onset or last known seen well \>24 hours

Primary outcome measure(s)

GOOD OUTCOME: A MODIFIED RANKIN SCORE (mRS) OF 0-3 — 90 DAYS +/-14 DAYS
Functional outcome at 3 months assessed using the mRS scale by a blinded evaluator in a validated structured interview. mRS ranges from 0 to 6 (0: No symptoms; 1: Mild symptoms, but can perform all normal work and daily activities; 2: Mild disability; does not do everything as before, but can care for themselves without assistance; 3: Moderate disability; needs some assistance with certain tasks, but can walk independently; 4: Moderately severe disability; cannot walk independently or manage basic needs without assistance; 5: Severe disability; is bedridden or wheelchair-bound and requires full-time assistance; 6: The person has died.

Trial sites (1)

Facility	City	Region	Status
Neurology Department, German Trias I Pujol Hospital.	Badalona	Barcelona

More Germans Trias i Pujol Hospital trials in Spain

Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume Recruiting

Study of the Brain's Natural Cleaning System in Potential Organ Donors. Recruiting

Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection. Recruiting

Endoscopic Versus Robotic Myotomy for Treatment of Achalasia Active, not recruiting

Chronic Insomnia in Non-Cancer Pain Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07728734 on ClinicalTrials.gov ↗ ← All trials in Spain