NCT06816641

Brief Summary

The aim of this study is to assess the safety and efficacy of surgical evacuation of spontaneous intracerebral hemorrhage.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

January 30, 2025

Last Update Submit

February 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Morbidity after surgical evacuation of Intracerebral hematoma

    Complications within first month

    1 month

  • Mortality after surgical evacuation of Intracerebral hematoma

    Death of patient within first month

    1 month

Secondary Outcomes (2)

  • Morbidity after surgical evacuation of Intracerebral hematoma

    3 months

  • Mortality after surgical evacuation of Intracerebral hematoma

    3 months

Study Arms (1)

Surgical evacuation of Intracerebral hemorrhage

OTHER

Surgical evacuation of Intracerebral hematoma

Procedure: Surgical Evacuation of Intracerebral Hemorrhage

Interventions

Surgical Evacuation of Intracerebral Hemorrhage

Surgical evacuation of Intracerebral hemorrhage

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with radiological findings of ICH.
  • Age group 20-70 years.

You may not qualify if:

  • Traumatic ICH or ruptured aneurysm or AVM or brain tumor.
  • Postoperative cranial surgery ICH.
  • Secondary hydrocephalus.
  • Patients with other comorbidities e.g., Liver cell failure and renal cell failure.
  • Patients with bleeding disorders.
  • Patients who are regular on anticoagulant or antiplatelet therapy.
  • Small sized ICH\< 30 ml.
  • GCS less than 6 preoperatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (3)

  • van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.

    PMID: 20056489BACKGROUND
  • Wilkinson DA, Pandey AS, Thompson BG, Keep RF, Hua Y, Xi G. Injury mechanisms in acute intracerebral hemorrhage. Neuropharmacology. 2018 May 15;134(Pt B):240-248. doi: 10.1016/j.neuropharm.2017.09.033. Epub 2017 Sep 22.

    PMID: 28947377BACKGROUND
  • Wong JM, Ziewacz JE, Ho AL, Panchmatia JR, Kim AH, Bader AM, Thompson BG, Du R, Gawande AA. Patterns in neurosurgical adverse events: open cerebrovascular neurosurgery. Neurosurg Focus. 2012 Nov;33(5):E15. doi: 10.3171/2012.7.FOCUS12181.

    PMID: 23116095BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed A Ragheb, Demonstrator

CONTACT

Ahmed S Mohamed, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of Neurosurgery

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 10, 2025

Study Start

January 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations