Predictors of Early Hematoma Expansion in Patients With Acute Intracerebral Hemorrhage (Clinical and Laboratory Study)

Not yet recruiting

• Conditions: ICH - Intracerebral Hemorrhage

• Registration Number: NCT06490978
• Lead Sponsor: Assiut University

Brief Summary

This study aim to develop inflammatory score based on proper integration of several inflammatory markers and investigate whether it was associated with hematoma expansion and poor outcomes in patients with ICH .

Detailed Description

Intracerebral hemorrhage(ICH) accounts for approximately a quarter of all stroke subtypes with high mortality and the survi- vors always have varying degrees of residual disability. However, few medical and surgical treatments are clearly beneficial comparing with ischemic stroke. Hematoma expansion, which is a determinant of poor outcomes, occurs in about 30% of ICH patients especially at the early stage. Attenuating hema- toma expansion is a compelling target for ICH treatment, while the outcomes have not been accordingly improved after curbing the growth of hematoma in several clinical trials. It will be more helpful if a predictor can identify the risk of hematoma expansion and poor outcome rapidly and accurately. Thus the antiexpansion treatment to the patients with positive of such predictor is likely to provide clinical benefits.

Study Timeline

• Study First Submitted: 2024-02-27
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Study Start: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients having spontaneous ICH aged 18 years or older admitted to a stroke unit within 24 hours After symptom onset .

Exclusion Criteria

1- patient have secondary ICH (cerebral aneurysm, Moyamoya syndrome, arteriovenous malformation, tumor, trauma or hemorrhagic transformation from brain infarction); (2)patient have primary intraventricular hemorrhage (IVH); (3)patients with historical modified Rankin scale (mRS) score greater than 1 (4) patient refused to be enrolled.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies.	Baseline	The current study suggests inflammatory score consisting of appropriate integration of NLR, PLR, MLR, SII, LDH, and CRP is independently associated with hematoma expansion and poor outcomes of different terms in ICH patients, including secondary neurological deterioration within 48 hours, 30-day mortality, and 3-month poor mRS. Moreover, inflammatory score greater than or equal to 5 is validated as an appropriate predictor of hematoma expansion and poor outcomes with good accuracies

Secondary Outcome Measures

Name	Time	Method
Secondary outcome	One year	Secondary (subsidiary) : 1. inflammatory score based on proper integration of several inflammatory markers; 2. investigate whether it was associated with hematoma expansion in patients with ICH Helping . in better outcome and good prognosis; 3. prediction of secondary neurological deterioration within 48 hours, 30-day mortality, and 3- month poor mRS; Secondary (subsidiary) : 1. inflammatory score based on proper integration of several inflammatory markers; 2. investigate whether it was associated with hematoma expansion in patients with ICH Helping . in better outcome and good prognosis; 3. prediction of secondary neurological deterioration within 48 hours, 30-day mortality, and 3- month poor mRS