Spontaneous Intracranial HemorrhageNCT03899350
The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage
An observational study of Spontaneous Intracranial Hemorrhage and Spontaneous Intraparenchymal Cerebral Hemorrhage, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Intracranial Hemorrhage, Spontaneous Intraparenchymal Cerebral Hemorrhage, Spontaneous Cerebellar Haemorrhage
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All of the spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) patients receiving treatment in four clinical centers (Tangdu Hospital, Ankang Central Hospital, 987 Hospital of PLA Joint Logistic Support Force, and Nuclear Industry 215 Hospital of Shaanxi Province) who meet the screening criteria were invited to participate in this cohort study.
Who may be able to join
- Age 18-80；
- Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
- Admitted within 24h of ictus；
- Did not undertake treatment before enrollment;
- Informed consent to participate in the study.
Who cannot join
- The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
- Concurrent traumatic brain injury；
- Multiple intracerebral hemorrhage；
- Undertake any surgery after onset in other hospital；
- Refuse the treatment after admission;
- History of craniocerebral surgery；
Show all 15Show fewer
- Known advanced demential or disability before onset；
- Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
- Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
- Concurrent serious infectious disease (HIV, tuberculosis etc.)
- Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
- With indications of terminal brain hernia
- Pregnant or lactating females；
- Participation in another simultaneous trial of intracerebral hemorrhage treatment；
- Patients/relatives refuse to be followed up。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
Wei Guo, M.D Ph.D, 86-18729985168, 18729985168@163.com
Haixiao Liu, M.D, 86-15929315407, 56761311@qq.com
About this study
This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.
Read the detailed description
Spontaneous intracranial hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.
This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.
Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.
- Conditions
- Spontaneous Intracranial Hemorrhage, Spontaneous Intraparenchymal Cerebral Hemorrhage, Spontaneous Cerebellar Haemorrhage
- Being tested
- No intervention
- Keywords
- Treatment Efficacy, Intraparenchymal Hemorrhage, Surgery, Outcome, Prediction Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous Supratentorial Intracerebral Haemorrhage | Participants with spontaneous supratentorial intracerebral haemorrhage. Receives: Other: No intervention | |
| Spontaneous Intracerebellar Hemorrhage | Participants with spontaneous intracerebellar hemorrhage. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The mortality rate of patients undertook different treatments at 1 month.
Measured: 1 month after onset
Mortality
The mortality rate of patients undertook different treatments at 6 month.
Measured: 6 month after onset
Mortality
The mortality rate of patients undertook different treatments at 12 month.
Measured: 12 month after onset
Neurological Outcome Assessed by modified Rankin Scale (mRS) Score
The neurological function state of patients undertook different treatments at 1 month.
Measured: 1 month after onset
Neurological Outcome Assessed by mRS Score
The neurological function state of patients undertook different treatments at 6 month.
Measured: 6 month after onset
Neurological Outcome Assessed by mRS Score
The neurological function state of patients undertook different treatments at 12 month.
Measured: 12 month after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start15 Jul 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracranial HemorrhageStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, Study chair, Tang-Du HospitalWei Guo, Study director, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899350
- Sponsor's protocol ID
- TDSJWKICH
- Status last verified
- Sep 2023
- First submitted
- 7 Jan 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun GC, Chen XL, Hou YZ, Yu XG, Ma XD, Liu G, Liu L, Zhang JS, Tang H, Zhu RY, Zhou DB, Xu BN. Image-guided endoscopic surgery for spontaneous supratentorial intracerebral hematoma. J Neurosurg. 2017 Sep;127(3):537-542. doi: 10.3171/2016.7.JNS16932. Epub 2016 Sep 16.
PubMed 27636179Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Circulation. 2007 Oct 16;116(16):e391-413. doi: 10.1161/CIRCULATIONAHA.107.183689.
PubMed 17938297Hemphill 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 26022637Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
PubMed 30739747Liu H, Li D, Cai Y, Zheng L, Tan Z, Liu F, Gao F, Zhang H, Du Y, Zhou G, Sun F, Fan R, Wang P, Wang L, Ge S, Zhao T, Zhang T, Zhang R, Xie G, Qu Y, Guo W. Prognostic Significance of Preoperative Perihematomal Edema in Spontaneous Cerebellar Hemorrhage After Minimally Invasive Surgery. Neurocrit Care. 2025 Jun;42(3):794-803. doi: 10.1007/s12028-025-02221-4. Epub 2025 Feb 26.
PubMed 40011329
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage
- ClinicalTrials.gov ID
- NCT03899350
- Acronym / sponsor ID
- TDSJWKICH
- Conditions
- Spontaneous Intracranial Hemorrhage, Spontaneous Intraparenchymal Cerebral Hemorrhage, Spontaneous Cerebellar Haemorrhage
- Keywords
- Treatment Efficacy, Intraparenchymal Hemorrhage, Surgery, Outcome, Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.
Detailed description
Spontaneous intracranial hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.
This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.
Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Supratentorial Intracerebral Haemorrhage | – | Other: No interventionParticipants with spontaneous supratentorial intracerebral haemorrhage. |
| Spontaneous Intracerebellar Hemorrhage | – | Other: No interventionParticipants with spontaneous intracerebellar hemorrhage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) patients receiving treatment in four clinical centers (Tangdu Hospital, Ankang Central Hospital, 987 Hospital of PLA Joint Logistic Support Force, and Nuclear Industry 215 Hospital of Shaanxi Province) who meet the screening criteria were invited to participate in this cohort study.
Key inclusion criteria (5 listed)
- Age 18-80；
- Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
- Admitted within 24h of ictus；
- Did not undertake treatment before enrollment;
- Informed consent to participate in the study.
Key exclusion criteria (15 listed)
- The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
- Concurrent traumatic brain injury；
- Multiple intracerebral hemorrhage；
- Undertake any surgery after onset in other hospital；
- Refuse the treatment after admission;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Spontaneous Intracerebellar Hemorrhage, Spontaneous Supratentorial Intracerebral Haemorrhage |
Primary outcome
Mortality
Time frame: 1 month after onset
The mortality rate of patients undertook different treatments at 1 month.
Mortality
Time frame: 6 month after onset
The mortality rate of patients undertook different treatments at 6 month.
Mortality
Time frame: 12 month after onset
The mortality rate of patients undertook different treatments at 12 month.
Neurological Outcome Assessed by modified Rankin Scale (mRS) Score
Time frame: 1 month after onset
The neurological function state of patients undertook different treatments at 1 month.
Neurological Outcome Assessed by mRS Score
Time frame: 6 month after onset
The neurological function state of patients undertook different treatments at 6 month.
Neurological Outcome Assessed by mRS Score
Time frame: 12 month after onset
The neurological function state of patients undertook different treatments at 12 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 27636179Sun GC, Chen XL, Hou YZ, Yu XG, Ma XD, Liu G, Liu L, Zhang JS, Tang H, Zhu RY, Zhou DB, Xu BN. Image-guided endoscopic surgery for spontaneous supratentorial intracerebral hematoma. J Neurosurg. 2017 Sep;127(3):537-542. doi: 10.3171/2016.7.JNS16932. Epub 2016 Sep 16.
- Background: PubMed 17938297Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Circulation. 2007 Oct 16;116(16):e391-413. doi: 10.1161/CIRCULATIONAHA.107.183689.
- Background: PubMed 26022637Hemphill 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.
- Background: PubMed 30739747Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
- Derived from this study: PubMed 40011329Liu H, Li D, Cai Y, Zheng L, Tan Z, Liu F, Gao F, Zhang H, Du Y, Zhou G, Sun F, Fan R, Wang P, Wang L, Ge S, Zhao T, Zhang T, Zhang R, Xie G, Qu Y, Guo W. Prognostic Significance of Preoperative Perihematomal Edema in Spontaneous Cerebellar Hemorrhage After Minimally Invasive Surgery. Neurocrit Care. 2025 Jun;42(3):794-803. doi: 10.1007/s12028-025-02221-4. Epub 2025 Feb 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Qu study chair
Tang-Du Hospital
Wei Guo study director
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Intracranial Hemorrhage and Spontaneous Intraparenchymal Cerebral Hemorrhage, run by Tang-Du Hospital at 1 site 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 15 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wei Guo, M.D, Ph.D (86-18729985168, 18729985168@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 month after onset). The study lists 6 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 NCT03899350, which also lists 5 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 22 Sep 2023.