Analysis of Related Factors of Hematoma Morphology in Patients With Cerebral Hemorrhage and Prognosis Analysis of Different Regimens for Cerebral Hemorrhage
Conditions: Brain Hemorrhage
Sponsor: The Affiliated Hospital Of Guizhou Medical University

Analysis of hematoma morphology and related
factors in patients with cerebral hemorrhage
Prognosis Analysis of Different Treatment
Schemes for Intracerebral Hemorrhage research
proposal
Research direction：Cerebrovascular disease
Submission date：March 9th, 2022

1. Integrity Statement
The investigators of this trial earnestly implemented the "Clinical Trial Quality
Management Standard" and the protocol, which can ensure that the operation is
strictly in accordance with the trial procedures and the authenticity of the data
records.
There is no personal interest between the researcher and the subjects of this trial
2. Research topics
Analysis of related factors of hematoma morphology in patients with cerebral
hemorrhage and prognosis analysis of different regimens for cerebral hemorrhage 3.
3.Version number of the research proposal
V1.0
4. Source of funds
National Natural Science Foundation of China（81971126）
5. Execution table of research items
Project
Test preparation
Starting time
End Time
1
Project
preparation,
literature reading
2022.09.01
2023.05.31
2
Data collection and
follow-up
2023.06.01
2024.05.31
3
Data collation and
analysis
2024.06.01
2024.12.31
4
Summarize
2025.01.01
2025.05.31
6. Research Background
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.
7. Research purpose
Analyze the impact of early hematoma morphology on hematoma enlargement,
and optimize the treatment plan for cerebral hemorrhage, combined with clinical
guidance for treating patients with cerebral hemorrhage.
8. Inclusion and exclusion criteria
Inclusion criteria:
1. Age range from 18 to 80 years old;
2. Diagnosed as cerebral hemorrhage through head CT examination;
Exclusion criteria:
1. Multiple intracranial hemorrhage;
2. Intracranial hemorrhage caused by intracranial tumors, aneurysms, trauma,
infarction, or other lesions;
3. Coagulation dysfunction or history of taking anticoagulant drugs;
4. Infectious meningitis, systemic infection;
5. History of severe stroke, heart, kidney, liver, and lung dysfunction;
6. Severe cerebral hernia (dilated pupils, respiratory and circulatory failure);
7. Incomplete or lost basic or follow-up information in the hospital.
9.Design scheme, design pattern diagram
Taking patients with cerebral hemorrhage as the main research object, a
single-center, retrospective case-control study was used to collect inpatients in the

Affiliated Hospital of Guizhou Medical University from January 1, 2014 to August 31,
2022. The included cases were divided into a regular hematoma group and an
irregular hematoma group. The proportion of early hematoma expansion was
compared between the two groups, and the 90-day and 180-day prognosis of the
two groups were compared to explore the factors affecting the prognosis of patients
with cerebral hemorrhage.
Patients in the hematoma rule group were divided into three groups based on
different treatment methods: stereotactic intracranial hematoma puncture and
drainage
treatment
group,
decompressive
craniectomy
treatment
group,
neuroendoscopic treatment group, and drug treatment group. The prognosis of the
two groups of patients was compared; Using the same method, the irregular
components of hematoma were divided into three groups: stereotactic intracranial
hematoma puncture and drainage treatment group, decompressive craniectomy
treatment group, neuroendoscopic treatment group, and drug treatment group, to
explore the optimal treatment plan for patients with cerebral hemorrhage.

10. Sample Size Estimation
Based on the assumption that 38% of ICH patients would have an mRS score of 0-3
after sMIS, we estimated that 180 participants would provide 95% power with an
alpha level of 0.05. The allowable error β is 0.1, and the detection efficiency is 0.9.
The sample size calculation formula is as follows:
z2αp(1-p)
N=
δ2
11. Methods of random and covert grouping
none.
12. Blind method
This study was retrospective and did not require blinding.
13. Measurement indicators

main indicators:
Hematoma expansion ratio within 24 hours of onset;
90-day, 180-day mRS score;
Secondary indicators:
in-hospital mortality;
90-day, 180-day GCS score, mortality;
14. Definition of Validation of Participants
main indicators:
The hematoma did not expand within 24 hours of onset;
90 days, 180 days mRS score ≤3 points;
Secondary indicators:
did not die during hospitalization;
90 days, 180 days GCS score > 12 points, no death;
15.Definition, identification method and management system of
adverse events and adverse reactions
Definition
Refers to an adverse medical event that occurs after a patient or clinical
experimenter receives a drug or device, but does not necessarily have a causal
relationship with the treatment;
Determination of the severity of adverse events:
Mild: does not affect daily activities;
Moderate: affects the patient's daily activities;
Severe: loss of ability to perform daily activities;
Serious: Refer to Serious Adverse Events.
Determination of serious adverse events
Death
life-threatening
Longer length of hospital stay
Permanent or severe disability
Causes congenital deformities and defects
Reporting system
Any serious adverse reaction, whether related to the drug or not, that occurred
during the course of the clinical trial or within 30 days of the last treatment, should
be reported immediately by telephone to the clinical team leader (PI) and within 24
hours. Ethics committee report, and the sponsor reports to the State Drug

Administration.
16. Ethical considerations
This study was approved by the Human Ethics Committee of Guizhou Medical
University
Ethics Committee: Ethics Committee of Affiliated Hospital of Guizhou Medical
University
Approval procedure: Fill out the ethics approval application form and attach relevant
approval materials.
Informed consent: Before each patient is enrolled in this study, the research
physician is responsible for fully and comprehensively introducing the purpose of this
study, the performance of the drug, its possible toxic and side effects and possible
risks to the patient. Patients should be informed of their rights, risks and benefits to
be assumed. Patients should sign an informed consent form before enrollment.
Ethical norms: This clinical trial must comply with the Declaration of Helsinki (2000
edition), the Good Clinical Practice for Drugs (GCP) promulgated by the SFDA, and
related regulations. Before the start of the trial, the study could be started only after
the protocol was approved by the ethics committee of the lead unit. Any
modification of the trial protocol during clinical research should be reported to the
ethics committee and filed.
Registration time: 2017.11
Registration institution: Affiliated Hospital of Guizhou Medical University
Approval number: 2019 Ethical Review No. (114)
17. Recruitment of participants
In this retrospective study, patients admitted to the Affiliated Hospital of Guizhou
Medical University from January 1, 2014 to August 31, 2022 were collected. Patients
with cerebral hemorrhage were collected according to the head CT at the time of
admission.
18. Baseline Indicators and Observations
Baseline data included admission blood pressure, baseline intracerebral hemorrhage
score, Glasgow Coma Scale (GCS) score, National Institutes Of Health Stroke Scale
(NIHSS) score, Time to baseline CT scan, hematoma volume on admission, whether
there was rupture into the ventricle, Grabe score (oGS), modified Grabe score (mGS),
and presence of obstructive hydrocephalus. Through telephone follow-up, the
patients' premorbid disability, 90-day and 180-day clinical prognosis were assessed
using the modified Rankin scale. An mRS score of 0-3 was classified as good

prognosis and 4-6 as poor prognosis.
19. Standard Operating Procedures
Drug treatment group: ①General treatment: Based on high-level nursing care and
close and continuous attention to the patient's vital signs, the patient was instructed
to stay in bed continuously, inhaled oxygen, and instructed 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.
Stereotactic intracranial hematoma puncture surgery group: On the basis of drug
therapy, minimally invasive surgery was performed. Minimally invasive surgery: 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. The patients in the operation group were
also given medical drug treatment after the operation, and the complications
occurred during the course of the disease were treated actively.
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: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.
20. Statistical analysis methods
Statistical analysis was performed using SPSS 25.0 software (SPSS, Chicago, IL, USA).
Categorical variables, such as gender, drinking history, smoking history, hypertension
history, diabetes history, baseline intraventricular hemorrhage, early hematoma
expansion,
in-hospital
mortality,
90-day
mortality,
etc.,
were
expressed
as
percentages. If continuous variables conform to a normal distribution, such as age,
admission systolic blood pressure, and admission diastolic blood pressure, they are
expressed as mean ± SD; if continuous variables do not conform to a normal
distribution, such as admission GCS score, admission NIHSS score, baseline ICH
volume, incidence Time to CT, oGS score, mGS score, 90-day mRS score, etc., were
expressed as the median (inter-quartile range [IQR]). Differences between groups
were assessed using the chi-square test, Fisher's exact test, Student t test, or
Mann-Whitney U test (depending on data type). The level of significance was set at P
value < 0.05.
21. Management system for participants
1. The researcher collects the patient's name, ID number, home address, contact
information and other personal information in a timely manner, as well as current
illness history, past history, auxiliary examination results and other information;
2. Arrange follow-up visits for patients, and complete various examinations in strict
accordance with the regulations;
3. Inform the patient to keep the research method confidential, and at the same time
require the patient not to disclose the experimental research data at will;
22. Specimen management system
(1) Collection of specimens
1. Specimens are collected by medical staff who have received training on specimen

collection, preservation and transportation knowledge and sent to the laboratory;
2. Collect blood samples with a vacuum tube, and deliver the blood samples to the
laboratory two hours after collection. After centrifugation, use a disposable pipette
to draw serum or plasma into a 1.5ml centrifuge tube sterilized by autoclaving, and
enter the patient's basic information and serial number;
3. All the above containers for clinical specimen collection, such as test tubes or
centrifuge tubes, should be autoclaved and sealed before use.
(2) Transportation of specimens
After the specimens are collected, they should be sealed, labelled (posted) with the
name, date of collection, and whether there is any infectious disease pathogen. If the
delivery time is more than two hours, it must be sent to the laboratory in an ice box.
(3) Receipt of specimens
Strictly check and double-sign all kinds of samples, check and check in a timely
manner, and all samples that do not meet the requirements will be returned with
written records. All specimens involving infectious diseases must be marked with the
name of the infectious disease and the source of the sample. and the person
submitting the inspection;
The staff should carefully check the name, contact number, hospital number,
ward bed number, inspection items, etc., and label the samples. Those who do not
meet the requirements should be recorded and contacted with the applying
physician.
(4) Handling of specimens
Specimen processing is strictly carried out in accordance with the operation
instructions of each test item. Experimenters entering the experimental area must
wear special work clothes, gloves, masks, hats, and shoes. The sample should be
marked with the serial number, date, user, and detailed experimental records and
usage records.
(5) Preservation of specimens
Destroy the remaining biological samples and the biological samples after
inspection in accordance with the relevant provisions of the "Medical Waste
Management Regulations" and "Medical Waste Management Measures for Medical
and Health Institutions".
23. Drug and equipment management system
Store the medicines with reference to the instructions of the medicines, and check
and confirm before administration;
The surgical instruments shall be disinfected and sterilized according to relevant

regulations after each use;
Dispose of single-use items after use and cannot be reused.
24. Treatment and management of participants after the trial
The trial was a retrospective study, participants continued treatment according to
their disease, and the researchers followed up regularly.