Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage

Official title

Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage

Overview

To analyze the influence of early hematoma morphology on hematoma expansion, optimize the treatment plan for cerebral hemorrhage, and guide the treatment of patients with cerebral hemorrhage in combination with clinical practice.

Detailed description

Intracerebral hemorrhage refers to the hemorrhage caused by the rupture of blood vessels in the non-traumatic brain parenchyma, accounting for 20% to 30% of all strokes, with an acute mortality rate of 30% to 40%. Different degrees of movement disorders, language disorders, etc. will be left behind. It is of great clinical significance to deeply explore the relevant factors and effective treatment plans for the evolution of cerebral hemorrhage. 30% of hematomas can still have active bleeding within 20 hours of onset. The INTERACT test defines hematoma expansion as 24-48 hours of repeated non-enhanced CT. The increase in hematoma volume \>12.5ml or 33% of the original volume is the cause of neurological deterioration and abnormality. An important cause of poor prognosis, studies have confirmed that irregular hematoma morphology is a strong predictor of hematoma expansion. Treatment of cerebral hemorrhage currently includes medical treatment and surgical treatment. Surgical treatment has become an important method for the treatment of ICH due to its advantages of rapid removal of hematoma, relief of high intracranial pressure, and release of mechanical compression. However, whether surgery can reduce the mortality of patients with cerebral hemorrhage and improve neurological damage is still controversial. Surgical operations include dstereotactic intracranial hematoma puncture and drainage, decompressive craniectomy , neuroendoscopic. Currently, there are large randomized controlled trials at home and abroad on minimally invasive hematoma evacuation. The treatment of spontaneous intracerebral hemorrhage is safe, but the effectiveness of minimally invasive surgery is unclear due to inconsistent bleeding volume, surgical trauma, and hematoma morphology.

Interventions

• Procedure Stereotactic intracranial hematoma puncture
  Check the CT scan of the patient's brain, find out the largest hematoma level of the patient, measure the coordinates of the puncture center, locate and mark the skull surface according to the coordinates obtained from the measurement, select the puncture point under the stereotaxic instrument, and mainly avoid important blood vessels , nerves and functional areas. Use an electric drill to drill the puncture needle into the center of the hematoma, and slowly aspirate the hematoma from the side h
• Procedure decompressive craniectomy
  Prior to the procedure, all patients obtained endotracheal intubation under general anesthesia following the informed consent provided by their family members. Upon identifying the hematoma's location through CT imaging, the surgeon made a linear or horseshoe-shaped incision on the scalp and subsequently opened the dura mater after creating a bone flap. The hematoma was punctured using a brain needle, allowing for effective decompression. The cerebral cortex was incised along the cerebral gyri,
• Procedure Neuroendoscopic
  The patient's preoperative CT and MR imaging data were fused with a neuronavigation system to avoid important functional areas and select the closest point of the hematoma to the cortex as the location point. Routine craniotomy was performed with a 2\*3 cm bone window, the puncture direction was repositioned by neuronavigation, the sheath was placed at the center of the hematoma, the core was removed, the endoscope was gradually aspirated, and the bleeding was stopped with electrocoagulation if

Primary outcome measures

• Hematoma expansion rate 24 hours after onset [Time frame: 24 hours of onset]
• 90-day Modified Rankin Rating Scale score; [Time frame: 90-day]

Secondary outcome measures (1)

• 90-day mortality [Time frame: 90-day]

Eligibility criteria

Inclusion criteria

• Age 18-80 years old;
• Intracerebral hemorrhage was diagnosed by head CT examination;

Exclusion criteria

• Multiple intracranial hemorrhage;
• Intracranial hemorrhage caused by intracranial tumor, aneurysm, trauma, infarction or other lesions;
• Coagulation disorders or a history of taking anticoagulants;
• Infectious meningitis, systemic infection;
• History of severe stroke, heart, kidney, liver and lung dysfunction in the past;
• Severe brain herniation (mydriasis, respiratory and circulatory failure);
• Incomplete or missing basic data or follow-up information in the hospital.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

China · 1 center

• Guizhou Medical University Affiliated Hospital — Guiyang

Publications

• Zhao X, Ma W, Zhang W, Deng M, Wang L, Wu G, Ren S. Optimal hematoma volume cutoffs and efficacy of minimally invasive surgery for thalamic hemorrhage: a propensity score-matched analysis. BMC Neurol. 2026 Feb 27;26(1):217. doi: 10.1186/s12883-026-04748-1. PMID 41749143
• Wu Q, Huang L, Chen N, Ren S, Ye F, Zhao X, Wu G, Wang L. Quantification of hounsfield unit difference in heterogeneous hematoma predicts poor functional outcomes in acute intracerebral hemorrhage. Sci Rep. 2025 Sep 26;15(1):33007. doi: 10.1038/s41598-025-18409-9. PMID 41006456
• Wu Q, Chen N, Ren Y, Ren S, Ye F, Zhao X, Wu G, Wang L. Morphological characteristics of CT blend sign predict hematoma expansion and outcomes in intracerebral hemorrhage in elderly patients. Front Med (Lausanne). 2024 Oct 1;11:1442724. doi: 10.3389/fmed.2024.1442724. eCollection 2024. PMID 39411190

Identifiers

NCT: NCT05548530 · JZSJK0828

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗