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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,688
- 试验地点
- 1
- 主要终点
- GOOD OUTCOME: A MODIFIED RANKIN SCORE (mRS) OF 0-3
研究概览
简要总结
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.
详细描述
- OBJECTIVES:
1.1. Primary objective: To prospectively validate, in a multicenter, real-world clinical practice setting, the predictive value of a novel, simple, and easy-to-apply prognostic scale for determining functional recovery at 90 days, assessed using the modified Rankin Scale (mRS), in patients with intracerebral hemorrhage who received maximal treatment.
1.2. Secondary objectives:
1.2.1. To prospectively validate, in a multicenter, real-world clinical practice setting, the predictive value of a simple and easy-to-apply prognostic scale for determining long-term functional recovery (at 6 months and 1 year), assessed using the mRS, in patients with intracerebral hemorrhage who received maximal treatment.
1.2.2. To prospectively validate, in a multicenter, real-world clinical practice setting, the predictive value of a simple and easy-to-apply prognostic scale for determining mortality and "mortality or severe disability" (defined as mRS 5 or 6) at 90 days, 6 months, and 1 year in patients with intracerebral hemorrhage who received maximal treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •Time from symptom onset or last known seen well ≤ 24 hours.
- •Signed informed consent by the patient or their representative.
排除标准
- •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
研究组 & 干预措施
Adult consecutive patients with spontaneous intracranial hemorrhage admitted in CSC
干预措施: CLINICAL SCORE TO PREDICT FUNCTIONAL OUTCOME (Other)
Adult consecutive patients with spontaneous intracranial hemorrhage admitted in CSC
干预措施: 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 (Other)
结局指标
主要结局
GOOD OUTCOME: A MODIFIED RANKIN SCORE (mRS) OF 0-3
时间窗: 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.
次要结局
- HEALTH-RELATED QUALITY OF LIFE(90 DAYS, 6 MONTHS and 12 MONTHS (+/- 14 DAYS))
- GOOD OUTCOME: A MODIFIED RANKIN SCORE (mRS) OF 0-3(6 MONTHS AND 12 MONTHS (+/- 14 DAYS))
- MORTALITY OR COMBINED MORTALITY+SEVERE DEPENDENCY: A MODIFIED RANKIN SCALES (mRS) OF 6 OR 5+6(90 DAYS, 6 MONTHS and 12 MONTHS (+/- 14 DAYS))
研究者
Monica Millan Torne
NEUROLOGIST, MD, PHD
Germans Trias i Pujol Hospital