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Cerebrovascular DisordersSTIPENCT04647162

A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage

A study testing hematoma evacuation by craniotomy, hematoma evacuation by stereotactic puncture and hematoma evacuation by neuroendoscopy in people with Cerebrovascular Disorders and Pontine Hemorrhage, run by West China Hospital at 20 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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%. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hematoma evacuation by craniotomy, hematoma evacuation by stereotactic puncture and hematoma evacuation by neuroendoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
20 sitesChina
Study dates
1 Jan 2022to Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of PPH: patients have acute hemorrhage mainly in pons with a definite history of hypertension.
  • GCS 5~7 and HV≥5ml on admission (the HV in intraventricular system being excluded).
  • Family members consenting to randomize and signing informed consent form (ICF).
  • Time from onset to admission less than 24 hours.
  • Age:18 years or older.

Who cannot join

  • Structural lesions such as brainstem cavernous malformation, arteriovenous malformation, aneurysm, tumor apoplexy.
  • GCS≥8 and HV<5ml.
  • Time from onset to admission over 24 hours.
  • Patients with platelet count < 100,000, International Normalized Ratio (INR)> 1.4, or an elevated prothrombin time (PT) and activated partial thromboplastin time (APTT).
  • Multiple ICH.
  • Accompanying hydrocephalus that requires surgical management
Show all 13Show fewer
  • Irreversible brainstem failure (bilateral fixed, dilated pupils and extensor motor posturing, GCS≤4).
  • A previous history of ICH.
  • Any serious concurrent illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
  • Pregnant patients.
  • Patients' family members refuse HE.
  • Any other condition that the investigator believes would present a significant hazard to the subject if the investigational therapy were initiated.
  • Participating in another simultaneous trial of ICH treatment.

Trial locations and contacts

20 sites in 1 country.

Chao You, MD contact

+86 028-85422488

youchao@vip.126.com

Qiang He, MD contact

+86 15099189463

heqiang629@126.com

20 sites in 1 country

China20 sites, 20 recruiting

  • The Third Hospital of the People's Liberation Army

    Baoji

    Rongjun Zhang

    Recruiting

  • The seventh medical center of the Army General Hospital

    Beijing

    Hongtian Zhang, MD

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Chao You, MD

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Dezhi Kang, MD

    Recruiting

  • Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine

    Gaozhou, Guangdong

    Jinhua Yang, MD

    Recruiting

  • Guangdong Sanjiu Brain Hospital

    Guangzhou, Guangdong

    Linsen Mu, MD

    Recruiting

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

    Fengqiang Liu

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Hongsheng Liang, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Hongwei Cheng, MD

    Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan

    Zongping Li, MD

    Recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

    Xiaoping Tang, MD

    Recruiting

  • General Hospital of the Eastern Theater

    Nanjing, Jiangsu

    Chiyuan Ma, MD

    Recruiting

  • Huashan Hospital of Fudan University

    Shanghai

    Jian Yu, MD

    Recruiting

  • Shanghai No.10 hospital

    Shanghai

    Liang Gao, MD

    Recruiting

  • Xuhui Hospital of Zhongshan Hospital affiliated to Fudan

    Shanghai

    Shujie Sun, MD

    Recruiting

  • University of Chinese Academy of Sciences Shenzhen Hospital

    Shenzhen, Guangdong, 518000

    Xuezheng Fan, MD, 18126081550, 835646710@qq.com

    Recruiting

  • The Second Affiliated Hospital of South China University of Technology

    Shenzhen, Guangdong

    Jiangang Liu, MD

    Recruiting

  • Shanxi Bethune hospital

    Taiyuan, Shanxi

    Xinming Ding, MD

    Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Zhan Liu, MD

    Recruiting

  • Zhuhai People's Hospital

    Zhuhai, Guangdong

    Gang Chen, MD

    Recruiting

Other trials in China

About this study

Official title: Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial

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.

Read the detailed description

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.

Being tested
hematoma evacuation by craniotomy, hematoma evacuation by stereotactic puncture, hematoma evacuation by neuroendoscopy, life support
Medical subject headings
Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hematoma evacuation by craniotomyProcedure or surgery

    The intervention method of hematoma evacuation is under craniotomy.

  • hematoma evacuation by stereotactic punctureProcedure or surgery

    The intervention method of hematoma evacuation is under stereotactic puncture.

  • hematoma evacuation by neuroendoscopyProcedure or surgery

    The intervention method of hematoma evacuation is under neuroendoscopy.

  • life supportOther

    The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。

Study groups in NCT04647162
Study groupRoleWhat they receive
medical groupActive comparatorPatients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
Receives: Other: life support
surgical groupExperimentalPatients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
Receives: Procedure: hematoma evacuation by craniotomy; Procedure: hematoma evacuation by stereotactic puncture; Procedure: hematoma evacuation by neuroendoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Outcome Number 1: Rate of Mortality

    Percentage of participants who died during the first 30 days after randomization.

    Measured: 30 days from randomization

  2. 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.

    Measured: 30 days from randomization

  3. Safety Outcome Number 3: Rate of Symptomatic Rebleeding

    The difference in the rate of symptomatic rebleeding 72 hours post surgery.

    Measured: 72 hours post surgery

Secondary outcomes (6)

  1. the rate of hematoma clearance 3 days after surgery

    the rate of hematoma clearance 3 days after surgery

    Measured: 3 days after surgery

  2. all-cause mortality at 365 days

    all-cause mortality at 365 days

    Measured: 365 days after surgery

  3. 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.

    Measured: 30 days, 90 days, 180 days, and 365 days after surgery

  4. The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days

    The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days

    Measured: 180 days and 365 days after surgery

  5. 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.

    Measured: 180 days and 365 days after surgery

  6. 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

    Measured: 180 days and 365 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2020
  2. Study start1 Jan 2022
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A sample size of 60 would be required to demonstrate a significant level of 5% (two-sided) with 80% power. Considering the 6% missing rate during follow-up, the total sample size was 64 cases with 16 and 48 cases in MT and HE group, respectively.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647162
Sponsor's protocol ID
STIPE
Acronym
STIPE
Status last verified
Dec 2023
First submitted
17 Nov 2020
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Morotti A, Jessel MJ, Brouwers HB, Falcone GJ, Schwab K, Ayres AM, Vashkevich A, Anderson CD, Viswanathan A, Greenberg SM, Gurol ME, Romero JM, Rosand J, Goldstein JN. CT Angiography Spot Sign, Hematoma Expansion, and Outcome in Primary Pontine Intracerebral Hemorrhage. Neurocrit Care. 2016 Aug;25(1):79-85. doi: 10.1007/s12028-016-0241-2.

    PubMed 26759226

  • Ye Z, Huang X, Han Z, Shao B, Cheng J, Wang Z, Zhang Z, Xiao M. Three-year prognosis of first-ever primary pontine hemorrhage in a hospital-based registry. J Clin Neurosci. 2015 Jul;22(7):1133-8. doi: 10.1016/j.jocn.2014.12.024. Epub 2015 May 14.

    PubMed 25982189

  • Tao C, Li H, Wang J, You C. Predictors of Surgical Results in Patients with Primary Pontine Hemorrhage. Turk Neurosurg. 2016;26(1):77-83. doi: 10.5137/1019-5149.JTN.12634-14.1.

    PubMed 26768872

  • Huang K, Ji Z, Sun L, Gao X, Lin S, Liu T, Xie S, Zhang Q, Xian W, Zhou S, Gu Y, Wu Y, Wang S, Lin Z, Pan S. Development and Validation of a Grading Scale for Primary Pontine Hemorrhage. Stroke. 2017 Jan;48(1):63-69. doi: 10.1161/STROKEAHA.116.015326. Epub 2016 Dec 8.

    PubMed 27932606

  • Indredavik B, Bakke F, Slordahl SA, Rokseth R, Haheim LL. Stroke unit treatment. 10-year follow-up. Stroke. 1999 Aug;30(8):1524-7. doi: 10.1161/01.str.30.8.1524.

    PubMed 10436094

  • Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.

    PubMed 26022637

  • Steiner T, Al-Shahi Salman R, Beer R, Christensen H, Cordonnier C, Csiba L, Forsting M, Harnof S, Klijn CJ, Krieger D, Mendelow AD, Molina C, Montaner J, Overgaard K, Petersson J, Roine RO, Schmutzhard E, Schwerdtfeger K, Stapf C, Tatlisumak T, Thomas BM, Toni D, Unterberg A, Wagner M; European Stroke Organisation. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage. Int J Stroke. 2014 Oct;9(7):840-55. doi: 10.1111/ijs.12309. Epub 2014 Aug 24.

    PubMed 25156220

  • Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3.

    PubMed 3992454

  • Ichimura S, Bertalanffy H, Nakaya M, Mochizuki Y, Moriwaki G, Sakamoto R, Fukuchi M, Fujii K. Surgical Treatment for Primary Brainstem Hemorrhage to Improve Postoperative Functional Outcomes. World Neurosurg. 2018 Dec;120:e1289-e1294. doi: 10.1016/j.wneu.2018.09.055. Epub 2018 Sep 19.

    PubMed 30244074

  • Mangiardi JR, Epstein FJ. Brainstem haematomas: review of the literature and presentation of five new cases. J Neurol Neurosurg Psychiatry. 1988 Jul;51(7):966-76. doi: 10.1136/jnnp.51.7.966.

    PubMed 3060565

  • Rohde V, Berns E, Rohde I, Gilsbach JM, Ryang YM. Experiences in the management of brainstem hematomas. Neurosurg Rev. 2007 Jul;30(3):219-23; discussion 223-4. doi: 10.1007/s10143-007-0081-9. Epub 2007 May 8.

    PubMed 17486379

  • Murata Y, Yamaguchi S, Kajikawa H, Yamamura K, Sumioka S, Nakamura S. Relationship between the clinical manifestations, computed tomographic findings and the outcome in 80 patients with primary pontine hemorrhage. J Neurol Sci. 1999 Aug 15;167(2):107-11. doi: 10.1016/s0022-510x(99)00150-1.

    PubMed 10521548

  • Cao S, Zheng M, Hua Y, Chen G, Keep RF, Xi G. Hematoma Changes During Clot Resolution After Experimental Intracerebral Hemorrhage. Stroke. 2016 Jun;47(6):1626-31. doi: 10.1161/STROKEAHA.116.013146. Epub 2016 Apr 28.

    PubMed 27125525

  • Wilkinson DA, Keep RF, Hua Y, Xi G. Hematoma clearance as a therapeutic target in intracerebral hemorrhage: From macro to micro. J Cereb Blood Flow Metab. 2018 Apr;38(4):741-745. doi: 10.1177/0271678X17753590. Epub 2018 Jan 19.

    PubMed 29350086

  • Parraga RG, Possatti LL, Alves RV, Ribas GC, Ture U, de Oliveira E. Microsurgical anatomy and internal architecture of the brainstem in 3D images: surgical considerations. J Neurosurg. 2016 May;124(5):1377-95. doi: 10.3171/2015.4.JNS132778. Epub 2015 Oct 30.

    PubMed 26517774

Questions about this trial

What is this clinical trial studying?

A study testing hematoma evacuation by craniotomy, hematoma evacuation by stereotactic puncture and hematoma evacuation by neuroendoscopy in people with Cerebrovascular Disorders and Pontine Hemorrhage, run by West China Hospital at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chao You, MD (+86 028-85422488, youchao@vip.126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcome Number 1: Rate of Mortality (time frame: 30 days from randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04647162, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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