Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Hemorrhage
• Intervention / Treatment: Procedure: Stereotactic intracranial hematoma puncture; Procedure: decompressive craniectomy; Procedure: Neuroendoscopic

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Wu guofeng, Doctor; Phone Number: 13809431723
• Study Contact Backup: Name: Zhao xu, Master; Phone Number: 18785775120; Email: 1684283389@qq.com

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guizhou Medical University Affiliated Hospital
      • Contact: Wu guofeng, Doctor; Phone Number: 13809431723

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The inpatients admitted to the Emergency Neurology Department of the Affiliated Hospital of Guizhou Medical University from January 1, 2014 to August 31, 2022 were collected. According to the head CT at the time of admission, they were divided into the hematoma rule group and the hematoma irregular group

Description

Inclusion Criteria:

1. Age 18-80 years old;
2. Intracerebral hemorrhage was diagnosed by head CT examination;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stereotactic intracranial hematoma puncture treatment group; Check the CT slice of the patient's brain, find out the patient's largest hematoma level, measure the coordinates of the puncture center, locate and mark the skull surface according to the measured coordinates, select the puncture point under the stereotaxic instrument, 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 hole until the suction stops when there is resistance. The residual hematoma in CT and the location of the drainage tube were determined, and the position of the puncture needle was adjusted for the situation of brain CT. After the operation, according to the re-examination of cranial CT, urokinase was injected into the hematoma cavity through the drainage tube to dissolve the residual hematoma, and the operation process strictly followed aseptic operation.	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 hole until the suction stops when there is resistance. The residual hematoma in CT and the location of the drainage tube were determined, and the position of the puncture needle was adjusted for the situation of brain CT. After the operation, according to the re-examination of cranial CT, urokinase was injected into the hematoma cavity through the drainage tube to dissolve the residual hematoma, and the operation process strictly followed aseptic operation.
drug treatment group; General treatment: Based on high-level nursing care and close and continuous attention to the patient's vital signs, the patient is instructed to stay in bed continuously, give oxygen, and instruct the patient to avoid emotional agitation, etc. ②Special treatment: use hemostatic drugs, control blood pressure to prevent rebleeding, control blood sugar, control body temperature, anti-epilepsy, prevent infection, dehydration and lower intracranial pressure, etc. Multisystem complications such as tract hemorrhage should be actively managed.
decompressive craniectomy treatment group; 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, facilitating the separation of brain tissue to eliminate residual hematoma. Once hemostasis was ensured within the operative area, a silicone drainage tube was inserted, and the cranial bone flap was restored to its original position. In cases of severe brain edema or cerebral herniation, bone flap decompression was performed.	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, facilitating the separation of brain tissue to eliminate residual hematoma. Once hemostasis was ensured within the operative area, a silicone drainage tube was inserted, and the cranial bone flap was restored to its original position. In cases of severe brain edema or cerebral herniation, bone flap decompression was performed.
Neuroendoscopic treatment group; 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 there was considerable active bleeding. A drainage tube was placed, the bone flap was reset after surgery, and the scalp was sutured.	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 there was considerable active bleeding. A drainage tube was placed, the bone flap was reset after surgery, and the scalp was sutured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematoma expansion rate 24 hours after onset	The number of cases with enlarged hematoma after re-examination of head CT after 24 hours	24 hours of onset
90-day Modified Rankin Rating Scale score;	Modified Rankin Rating Scale score at 90 days after discharge，0-3 indicates good prognosis, 4-6 indicates poor prognosis, and 6 indicates death.	90-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	Proportion of patients who died 90 days after discharge	90-day

Collaborators and Investigators

• Sponsor: The Affiliated Hospital Of Guizhou Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: October 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; Hemorrhage; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Surgical Procedures, Operative; Neurosurgical Procedures; Decompression, Surgical; Craniotomy; Decompressive Craniectomy
• Other Study ID Numbers: JZSJK0828

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