Surgical Evacuation Of Spontaneous Intracerebral Hematoma: Clinical Outcomes and Prognostic Factors

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

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Haemorrhage (ICH)
• Intervention / Treatment: Procedure: Surgical Evacuation of Intracerebral Hemorrhage

Detailed Description

Spontaneous intracerebral hemorrhage (ICH), i.e., nontraumatic hemorrhage into the brain parenchyma with or without ventricles, is a severe type of stroke with high mortality rates. Systemic arterial hypertension and cerebral amyloid angiopathy represent the two main risk factors of primary ICH. (1) ICH is understood to injure surrounding brain tissue through the direct pressure effects of an acutely expanding mass lesion and through secondary physiological and cellular pathways triggered by the hematoma and its metabolized blood products. Direct pressure effects can include both local compression of immediately surrounding brain tissue and more widespread mechanical injury caused by increased intracranial pressure (ICP), hydrocephalus, or herniation. Early hematoma expansion, possibly driven by mechanical shearing of surrounding vessels by the initial hematoma, is common and a consistent predictor of worse ICH outcome. Secondary physiological and cellular injury mechanisms postulated to be triggered by ICH include cerebral edema, inflammation, and biochemical toxicity of blood products such as hemoglobin, iron, and thrombin. Several of the major medical therapies for ICH such as BP lowering and reversal of anticoagulation are aimed at limiting hematoma expansion. The search for effective medical treatments for protecting tissue from secondary post-ICH injury, like the search for effective neuroprotectants for ischemic stroke, has to date been unsuccessful. Surgical hematoma evacuation through craniotomy or minimally invasive approaches is aimed at both preventing further pressure-related injury and protecting against secondary physiological and cellular injury. (2) Hematoma evacuation may have therapeutic potential, based on the theoretical advantages of preventing or correcting the acute effects of hematoma and its blood products into the surrounding healthy brain parenchyma. However, because the most common sites of spontaneous ICH are the deep brain structures, such as the basal ganglia and the thalamus, a large layer of healthy brain tissue would be damaged. Additionally, neurosurgical procedures are not free of risks and adverse effects. Post-surgical complications (e.g., hemorrhages and infections) are common in this clinical scenario and carry high rates of morbidity and mortality. (3) Recent meta-analyses suggested the benefits of neurosurgical hematoma evacuation, especially when performed earlier and done using minimally invasive procedures. In MISTIE III (Minimally invasive surgery plus alteplase for intracranial hematoma evacuation), to confirm hemostasis and reduce the risk of rebleeding, the mean time from onset of ICH to surgery was 47 hours while the mean time from onset of ICH to treatment completion was 123 hours. Theoretically, the earlier the hematoma is removed, the better the outcome. Therefore, a higher rate of hematoma reduction within an earlier time course may be beneficial. (4) Although the role of open surgery to treat patients with spontaneous ICH remains controversial, the use of craniotomy for intracerebral hematoma drainage is the most common strategy applied in most centers and also the most studied approach so far. (5) Controversy remains over the efficacy of surgery for ICH, particularly in the early (<12 hours) and very early (<8 hours) time windows. Further data are needed before definitive conclusions can be reached. However, the sum of preclinical and clinical data strongly suggests that early evacuation may be a necessary component of any successful surgical approach. Furthermore, recent data have suggested improved safety of such procedures using modern minimally invasive approaches. Such approaches may minimize collateral injury, allow safe management of intraoperative bleeding, and prevent postoperative rebleeding, all of which may facilitate the potential value of early ICH evacuation. (6)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Ragheb, Demonstrator; Phone Number: 01025921006; Email: raghibov@gmail.com
• Study Contact Backup: Name: Ahmed S Mohamed, Professor; Phone Number: 0100 3911767

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University hospitals
    • Contact: Magdy M Amin, Professor; Phone Number: +20 109 0801900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients with radiological findings of ICH.

  • Age group 20-70 years.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgical evacuation of Intracerebral hemorrhage; Surgical evacuation of Intracerebral hematoma	Procedure: Surgical Evacuation of Intracerebral Hemorrhage; Surgical Evacuation of Intracerebral Hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity after surgical evacuation of Intracerebral hematoma	Complications from end of 1st month to end of 3rd month	3 months
Mortality after surgical evacuation of Intracerebral hematoma	Death of patient	3 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hematoma
• Other Study ID Numbers: Soh-Med--25-1-06MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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