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

NCT06490978 | Not Yet Recruiting

• 1 other identifier: ICH Expansion
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

ICH - Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome

  One year

Interventions

CT Brain RADIATION

Patient needs follow up ct brain , cbc , CRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Amal M. Tohamy, Lecturer

  Assiut University

  STUDY DIRECTOR

• Ahmed M. Tawfik, Lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed H. Abd El-samee, Master

CONTACT

01020232316; ahussein815@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: July 8, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07