Primary pontine hemorrhage (PPH) is not common but is the most catastrophic subtype of intracerebral hemorrhage, with acute mortality between 30% and 60%. For severe PPH, defined as Glasgow Coma score (GCS) \<8 and hematoma volume≥5ml, the mortality rate is as high as 80-100%. Guidelines from the American Heart Association and European Stroke Organization do not make definite specifications. More than a century after Finkelnburg first explored the brainstem for hematoma, however, plenty of researches have shown surgery can save lives and improve the prognosis for selective patients and can be an effective and safe treatment. This study is proposed to validate the safety of surgical treatment in severe primary pontine hemorrhage.
The study is being conducted from Jan 2022 to Nov 2024 in 20 neurosurgical units. This STIPE trial is an investigator-initiated, parallel (3:1 to surgical HE or MT), multi-centre, randomized controlled open-label trial following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will be conducted from Jan 2022 to Nov 2024 in 20 Tertiary hospitals in China. The flow chart of the clinical trial is presented in Figure 1. Neurosurgeons involved in the study are senior investigators with good clinical experience in sPPH management. Moreover, all investigators are well trained centrally according to the requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
The intervention method of hematoma evacuation is under craniotomy.
The intervention method of hematoma evacuation is under stereotactic puncture.
The intervention method of hematoma evacuation is under neuroendoscopy.
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGGaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine
Gaozhou, Guangdong, China
RECRUITINGGuangdong Sanjiu Brain Hospital
Guangzhou, Guangdong, China
RECRUITINGUniversity of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of South China University of Technology
Shenzhen, Guangdong, China
RECRUITINGZhuhai People's Hospital
Zhuhai, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGGeneral Hospital of the Eastern Theater
Nanjing, Jiangsu, China
RECRUITING...and 10 more locations
Safety Outcome Number 1: Rate of Mortality
Percentage of participants who died during the first 30 days after randomization.
Time frame: 30 days from randomization
Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Time frame: 30 days from randomization
Safety Outcome Number 3: Rate of Symptomatic Rebleeding
The difference in the rate of symptomatic rebleeding 72 hours post surgery.
Time frame: 72 hours post surgery
the rate of hematoma clearance 3 days after surgery
the rate of hematoma clearance 3 days after surgery
Time frame: 3 days after surgery
all-cause mortality at 365 days
all-cause mortality at 365 days
Time frame: 365 days after surgery
neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.
neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.
Time frame: 30 days, 90 days, 180 days, and 365 days after surgery
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
Time frame: 180 days and 365 days after surgery
The 5-level EuroQol five dimensions questionnaire (EQ-5D) version (EQ-5D-5L) at 180 days and 365 days
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The former descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The latter is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time frame: 180 days and 365 days after surgery
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
Time frame: 180 days and 365 days after surgery
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