Prognostic Analysis of Different Treatment Options for Cerebral Hemorrhage

Recruiting

• Conditions: Brain Hemorrhage
• Interventions: Procedure: decompressive craniectomy; Procedure: Stereotactic intracranial hematoma puncture; Procedure: Neuroendoscopic

• Registration Number: NCT05548530
• Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University

Brief Summary

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Status Verified: 2024-03
• Primary Completion: 2024-03-25
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
decompressive craniectomy treatment group	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.
Stereotactic intracranial hematoma puncture treatment group	Stereotactic intracranial hematoma puncture	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.
Neuroendoscopic treatment group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
90-day mortality	90-day	Proportion of patients who died 90 days after discharge

Trial Locations

Locations (1)

Guizhou Medical University Affiliated Hospital; 🇨🇳 Guiyang, Guizhou, China