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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: ICH - Intracerebral Hemorrhage
• Intervention / Treatment: Radiation: CT Brain

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ahmed H. Abd El-samee, Master; Phone Number: +02 01020232316; Email: ahussein815@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies.	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	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Amal M. Tohamy, Lecturer, Assiut University; Study Director: Ahmed M. Tawfik, Lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hematoma
• Other Study ID Numbers: ICH Expansion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No