the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients

NCT06653946 | Recruiting Phase 4

• 1 other identifier: 010120190
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Conditions

Ischemic Stroke; Alteplase Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group

  The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group

  48 days

Secondary Outcomes (3)

• the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group

  48 hours

• the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group

  48 hours

• the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group

  48 hours

Study Arms (2)

Hemorragic transformation group

ACTIVE COMPARATOR

262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.

Drug: Alteplase

non-hemorragic transformation group

ACTIVE COMPARATOR

454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase

Drug: Alteplase

Interventions

Alteplase DRUG

Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit

Also known as: group A

Hemorragic transformation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators enrolled individuals of both genders, aged between 18 and 75,
• All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
• All patients had Atrial fibrillation

You may not qualify if:

• The investigators excluded patients who had alteplase contraindications
• The investigators excluded patients who did not receive the total dose of alteplase for any reason.
• The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
• The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.
• The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.
• The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

RECRUITING

Related Publications (4)

• Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.

  PMID: 16731270 RESULT

• Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.

  PMID: 34515113 RESULT

• Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669.

  PMID: 12221155 RESULT

• Ahmed SR, Zeinhom MG, Ebied AAMK, Kamel IFM, Almoataz MA, Daabis AMA, Akl AZO, Mahmoud ELA, Alkhalefeh AG, Ouf SG, Mosbah SAA, Sirag IMI, Abouelnaga M, Khalil MFE. A multi-center study on the predictors of different subtypes of hemorrhagic transformation of brain infarction after thrombolysis in atrial fibrillation patients presented with embolic stroke. Sci Rep. 2025 May 5;15(1):15655. doi: 10.1038/s41598-025-97968-3.

  PMID: 40325067 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• mohamed G. Zeinhom, MD

  neurology department kafr el-sheikh university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed G. Zeinhom, MD

CONTACT

2001009606828; mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342; sherihan_rezq@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The study consisted of two distinct groups. The first group comprised 454 patients who did not experience hemorrhagic infarction, while the second group comprised 252 patients who experienced hemorrhagic infarction.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 23, 2024
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)