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 .

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Key information

Conditions

ICH - Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT Brain

Radiation

Patient needs follow up ct brain , cbc , CRP

Primary outcomes

primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies.

Time frame: 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 outcomes

Secondary outcome

Time frame: One year
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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed H. Abd El-samee, Master

CONTACT

[email protected]

01020232316 ext. +02

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 8, 2024
Registry last updated: Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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