Severe Spontaneous Intracranial HemorrhageNCT05975398
China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
An observational study of Severe Spontaneous Intracranial Hemorrhage and Long-term Antiplatelet Treatment, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Background: Although emergency surgery may reduce mortality in patients with severe spontaneous intracerebral hemorrhage (SSICH), the effectiveness and safety of surgical treatment among SSICH patients receiving long-term oral antiplatelet therapy (LOAPT) remain unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery
- What is being tested?
- Emergency neurosurgery and Conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with spontaneous, nontraumatic intracerebral hemorrhage enrolled in the ongoing CRISIH registry at participating clinical centers in China, receiving surgical or conservative management according to clinical indications and routine clinical practice. Severe spontaneous intracerebral hemorrhage (SSICH) is defined as supratentorial hematoma volume >30 mL, infratentorial hematoma volume >10 mL, midline shift >1 cm, large intraventricular hematoma, or Glasgow Coma Scale (GCS) score <13.
Who may be able to join
- Age 18 years or older.
- Spontaneous, nontraumatic intracerebral hemorrhage.
- Treatment with surgical or conservative management according to clinical indications and routine clinical practice.
- Written informed consent provided by the patient or legally authorized representative/family member.
Who cannot join
- Patients had cerebrovascular diseases associated with hemorrhage, such as intracranial aneurysm, cerebrovascular malformation, or intracranial tumors.
- Hemorrhagic transformation of cerebral infarction.
- Hemorrhage caused by cerebral venous thrombosis.
- Patients with severe coagulation disorder, such as hemophilia.
- Patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, or related conditions.
- Patients receiving other anticoagulation medications, including vitamin K antagonists or novel oral anticoagulants.
- Patients who died before arrival at the hospital, on arrival at the hospital, or within a short period (6 hours) after admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
JUN WU, MD, +8613426322945, wujunslf@126.com
Shuo Wang, MD
About this study
Background: Although emergency surgery may reduce mortality in patients with severe spontaneous intracerebral hemorrhage (SSICH), the effectiveness and safety of surgical treatment among SSICH patients receiving long-term oral antiplatelet therapy (LOAPT) remain unclear. The CRISIH registry was originally designed to evaluate the effect and safety of emergency surgery in SSICH patients receiving LOAPT and has subsequently continued as an ongoing multicenter registry of spontaneous intracerebral hemorrhage.
Methods: The CRISIH registry is an ongoing prospective, multicenter cohort registry conducted across participating clinical centers in China. The registry was initiated in November 2019 and is designed as a 10-year registry with continued recruitment and follow-up. Data from the initial five-year enrollment period are used for interim and secondary analyses, while recruitment and follow-up continue during the subsequent registry period. Clinical, radiological, surgical, laboratory, and follow-up information are collected using standardized case report forms. For the originally registered primary outcome, patients are followed until death or 6 months after the occurrence of primary hemorrhage; selected follow-up assessments and secondary analyses may extend beyond this period according to the registry protocol.
Read more
Study Design: The CRISIH registry was designed as a prospective, multicenter cohort registry of patients with spontaneous intracerebral hemorrhage. One originally registered comparative focus evaluates SSICH patients receiving LOAPT, comparing total mortality and survival outcomes between patients receiving emergency surgical treatment and those receiving conservative treatment. The safety of surgery is assessed by comparing postoperative hemorrhagic complications among operated patients with and without LOAPT. Based on the observed clinical characteristics and outcomes of patients receiving LOAPT, the registry also evaluates ischemic events after discontinuation of LOAPT and explores coagulation function assessment strategies in operated patients receiving LOAPT.
Objective: The CRISIH registry aims to prospectively evaluate clinical outcomes and management strategies in patients with spontaneous intracerebral hemorrhage. An originally registered focus of the registry is to assess the effectiveness and safety of emergency surgery among SSICH patients receiving LOAPT, thereby generating evidence to support future clinical management.
Secondary Analysis Update: The present update describes an interim secondary analysis of the ongoing CRISIH registry based on patients enrolled during the initial five-year period from November 2019 to December 2024. This analysis focuses on postoperative disorders of consciousness after surgery for spontaneous intracerebral hemorrhage, with consciousness status assessed at 30, 90, 180, and 365 days after surgery using the Coma Recovery Scale-Revised. This interim secondary analysis does not alter the ongoing registry design, recruitment status, or originally registered primary outcome.
- Conditions
- Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery, Complications, Disorders of Consciousness
- Being tested
- Emergency neurosurgery, Conservative treatment
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency neurosurgeryProcedure or surgery
Surgical evacuation for intracerebral hemorrhage
Conservative treatmentProcedure or surgery
Standard treatment for intracerebral hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mortality
Measured: From admission to 6 months after the occurrence primary hemorrhage
Secondary outcomes (2)
Postoperative intracranial bleeding
Measured: Within one week after surgery
Postoperative disorders of consciousness
Proportion of patients with postoperative disorders of consciousness after surgery for spontaneous intracerebral hemorrhage, assessed using the Coma Recovery Scale-Revised.
Measured: 30, 90, 180, 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.
- First posted3 Aug 2023
- Study start1 Nov 2019
- Primary completion30 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Severe Spontaneous Intracranial HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Shuyi Hospital, Beijing Anzhen Hospital, Guangzhou Red Cross Hospital, Beijing Pinggu District Hospital, Beijing Friendship Hospital, Wuxi No. 2 People's Hospital, Dezhou People's Hospital, Binzhou People's Hospital, First Affiliated Hospital of Fujian Medical University, Anxi County Hospital, Datong People's Hospital, Shijiazhuang Third Hospital, Qingyuan People's Hospital, Jingzhou Central Hospital, Jiuquan City People's Hospital, Zhoukou People's Hospital, Jincheng People's Hospital, The First Affiliated Hospital of Zhengzhou University, Xinyu People's Hospital
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975398
- Sponsor's protocol ID
- KY2019-096-02-1
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6.
PubMed 30319113Hemphill 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 26022637Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
PubMed 20651276Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
PubMed 23726393Goyal N, Tsivgoulis G, Malhotra K, Katsanos AH, Pandhi A, Alsherbini KA, Chang JJ, Hoit D, Alexandrov AV, Elijovich L, Fiorella D, Nickele C, Arthur AS. Minimally invasive endoscopic hematoma evacuation vs best medical management for spontaneous basal-ganglia intracerebral hemorrhage. J Neurointerv Surg. 2019 Jun;11(6):579-583. doi: 10.1136/neurintsurg-2018-014447. Epub 2019 Jan 7.
PubMed 30617144Wang WZ, Jiang B, Liu HM, Li D, Lu CZ, Zhao YD, Sander JW. Minimally invasive craniopuncture therapy vs. conservative treatment for spontaneous intracerebral hemorrhage: results from a randomized clinical trial in China. Int J Stroke. 2009 Feb;4(1):11-6. doi: 10.1111/j.1747-4949.2009.00239.x.
PubMed 19236490Xia Z, Wu X, Li J, Liu Z, Chen F, Zhang L, Zhang H, Wan X, Cheng Q. Minimally Invasive Surgery is Superior to Conventional Craniotomy in Patients with Spontaneous Supratentorial Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Jul;115:266-273. doi: 10.1016/j.wneu.2018.04.181. Epub 2018 May 3.
PubMed 29730105Lovelock CE, Molyneux AJ, Rothwell PM; Oxford Vascular Study. Change in incidence and aetiology of intracerebral haemorrhage in Oxfordshire, UK, between 1981 and 2006: a population-based study. Lancet Neurol. 2007 Jun;6(6):487-93. doi: 10.1016/S1474-4422(07)70107-2.
PubMed 17509483Baron TH, Kamath PS, McBane RD. Management of antithrombotic therapy in patients undergoing invasive procedures. N Engl J Med. 2013 May 30;368(22):2113-24. doi: 10.1056/NEJMra1206531. No abstract available.
PubMed 23718166Krittalak K, Sawanyawisuth K, Tiamkao S. Safety of withholding anticoagulation in patients with mechanical prosthetic valves and intracranial haemorrhage. Intern Med J. 2011 Oct;41(10):750-4. doi: 10.1111/j.1445-5994.2011.02579.x.
PubMed 22435901Cahill RA, McGreal GT, Crowe BH, Ryan DA, Manning BJ, Cahill MR, Redmond HP. Duration of increased bleeding tendency after cessation of aspirin therapy. J Am Coll Surg. 2005 Apr;200(4):564-73; quiz A59-61. doi: 10.1016/j.jamcollsurg.2004.11.002.
PubMed 15804471Korinth MC. Low-dose aspirin before intracranial surgery--results of a survey among neurosurgeons in Germany. Acta Neurochir (Wien). 2006 Nov;148(11):1189-96; discussion 1196. doi: 10.1007/s00701-006-0868-4. Epub 2006 Sep 21.
PubMed 16969624de Miguel-Diez J, Gomez Martinez A, Montero Martinez C. Perioperative and Periprocedural Management of Antithrombotic Therapy. Arch Bronconeumol (Engl Ed). 2019 May;55(5):229-230. doi: 10.1016/j.arbres.2018.07.019. Epub 2018 Sep 5. No abstract available. English, Spanish.
PubMed 30193947Douketis JD, Berger PB, Dunn AS, Jaffer AK, Spyropoulos AC, Becker RC, Ansell J. The perioperative management of antithrombotic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):299S-339S. doi: 10.1378/chest.08-0675.
PubMed 18574269Douketis JD, Bakhsh E. Perioperative management of antithrombotic therapy. Pol Arch Med Wewn. 2008 Apr;118(4):201-8.
PubMed 18575419
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）
- ClinicalTrials.gov ID
- NCT05975398
- Acronym / sponsor ID
- KY2019-096-02-1
- Conditions
- Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery, Complications, Disorders of Consciousness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Shuyi Hospital, Beijing Anzhen Hospital, Guangzhou Red Cross Hospital, Beijing Pinggu District Hospital, Beijing Friendship Hospital, Wuxi No. 2 People's Hospital, Dezhou People's Hospital, Binzhou People's Hospital, First Affiliated Hospital of Fujian Medical University, Anxi County Hospital, Datong People's Hospital, Shijiazhuang Third Hospital, Qingyuan People's Hospital, Jingzhou Central Hospital, Jiuquan City People's Hospital, Zhoukou People's Hospital, Jincheng People's Hospital, The First Affiliated Hospital of Zhengzhou University, Xinyu People's Hospital
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Aug 2023 (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.
Background: Although emergency surgery may reduce mortality in patients with severe spontaneous intracerebral hemorrhage (SSICH), the effectiveness and safety of surgical treatment among SSICH patients receiving long-term oral antiplatelet therapy (LOAPT) remain unclear. The CRISIH registry was originally designed to evaluate the effect and safety of emergency surgery in SSICH patients receiving LOAPT and has subsequently continued as an ongoing multicenter registry of spontaneous intracerebral hemorrhage.
Methods: The CRISIH registry is an ongoing prospective, multicenter cohort registry conducted across participating clinical centers in China. The registry was initiated in November 2019 and is designed as a 10-year registry with continued recruitment and follow-up. Data from the initial five-year enrollment period are used for interim and secondary analyses, while recruitment and follow-up continue during the subsequent registry period. Clinical, radiological, surgical, laboratory, and follow-up information are collected using standardized case report forms. For the originally registered primary outcome, patients are followed until death or 6 months after the occurrence of primary hemorrhage; selected follow-up assessments and secondary analyses may extend beyond this period according to the registry protocol.
Study Design: The CRISIH registry was designed as a prospective, multicenter cohort registry of patients with spontaneous intracerebral hemorrhage. One originally registered comparative focus evaluates SSICH patients receiving LOAPT, comparing total mortality and survival outcomes between patients receiving emergency surgical treatment and those receiving conservative treatment. The safety of surgery is assessed by comparing postoperative hemorrhagic complications among operated patients with and without LOAPT. Based on the observed clinical characteristics and outcomes of patients receiving LOAPT, the registry also evaluates ischemic events after discontinuation of LOAPT and explores coagulation function assessment strategies in operated patients receiving LOAPT.
Objective: The CRISIH registry aims to prospectively evaluate clinical outcomes and management strategies in patients with spontaneous intracerebral hemorrhage. An originally registered focus of the registry is to assess the effectiveness and safety of emergency surgery among SSICH patients receiving LOAPT, thereby generating evidence to support future clinical management.
Secondary Analysis Update: The present update describes an interim secondary analysis of the ongoing CRISIH registry based on patients enrolled during the initial five-year period from November 2019 to December 2024. This analysis focuses on postoperative disorders of consciousness after surgery for spontaneous intracerebral hemorrhage, with consciousness status assessed at 30, 90, 180, and 365 days after surgery using the Coma Recovery Scale-Revised. This interim secondary analysis does not alter the ongoing registry design, recruitment status, or originally registered primary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spontaneous, nontraumatic intracerebral hemorrhage enrolled in the ongoing CRISIH registry at participating clinical centers in China, receiving surgical or conservative management according to clinical indications and routine clinical practice. Severe spontaneous intracerebral hemorrhage (SSICH) is defined as supratentorial hematoma volume >30 mL, infratentorial hematoma volume >10 mL, midline shift >1 cm, large intraventricular hematoma, or Glasgow Coma Scale (GCS) score <13.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Spontaneous, nontraumatic intracerebral hemorrhage.
- Treatment with surgical or conservative management according to clinical indications and routine clinical practice.
- Written informed consent provided by the patient or legally authorized representative/family member.
Key exclusion criteria (7 listed)
- Patients had cerebrovascular diseases associated with hemorrhage, such as intracranial aneurysm, cerebrovascular malformation, or intracranial tumors.
- Hemorrhagic transformation of cerebral infarction.
- Hemorrhage caused by cerebral venous thrombosis.
- Patients with severe coagulation disorder, such as hemophilia.
- Patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, or related conditions.
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 |
|---|---|---|
| Emergency neurosurgerySurgical evacuation for intracerebral hemorrhage | Procedure or surgery | – |
| Conservative treatmentStandard treatment for intracerebral hemorrhage | Procedure or surgery | – |
Primary outcome
Total mortality
Time frame: From admission to 6 months after the occurrence primary hemorrhage
2 secondary outcomes
Postoperative intracranial bleeding
Time frame: Within one week after surgery
Postoperative disorders of consciousness
Time frame: 30, 90, 180, and 365 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Results publication: PubMed 30319113Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6.
- Results publication: 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.
- Results publication: PubMed 20651276Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
- Results publication: PubMed 23726393Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
- Results publication: PubMed 30617144Goyal N, Tsivgoulis G, Malhotra K, Katsanos AH, Pandhi A, Alsherbini KA, Chang JJ, Hoit D, Alexandrov AV, Elijovich L, Fiorella D, Nickele C, Arthur AS. Minimally invasive endoscopic hematoma evacuation vs best medical management for spontaneous basal-ganglia intracerebral hemorrhage. J Neurointerv Surg. 2019 Jun;11(6):579-583. doi: 10.1136/neurintsurg-2018-014447. Epub 2019 Jan 7.
- Results publication: PubMed 19236490Wang WZ, Jiang B, Liu HM, Li D, Lu CZ, Zhao YD, Sander JW. Minimally invasive craniopuncture therapy vs. conservative treatment for spontaneous intracerebral hemorrhage: results from a randomized clinical trial in China. Int J Stroke. 2009 Feb;4(1):11-6. doi: 10.1111/j.1747-4949.2009.00239.x.
- Results publication: PubMed 29730105Xia Z, Wu X, Li J, Liu Z, Chen F, Zhang L, Zhang H, Wan X, Cheng Q. Minimally Invasive Surgery is Superior to Conventional Craniotomy in Patients with Spontaneous Supratentorial Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Jul;115:266-273. doi: 10.1016/j.wneu.2018.04.181. Epub 2018 May 3.
- Results publication: PubMed 17509483Lovelock CE, Molyneux AJ, Rothwell PM; Oxford Vascular Study. Change in incidence and aetiology of intracerebral haemorrhage in Oxfordshire, UK, between 1981 and 2006: a population-based study. Lancet Neurol. 2007 Jun;6(6):487-93. doi: 10.1016/S1474-4422(07)70107-2.
- Results publication: PubMed 23718166Baron TH, Kamath PS, McBane RD. Management of antithrombotic therapy in patients undergoing invasive procedures. N Engl J Med. 2013 May 30;368(22):2113-24. doi: 10.1056/NEJMra1206531. No abstract available.
- Results publication: PubMed 22435901Krittalak K, Sawanyawisuth K, Tiamkao S. Safety of withholding anticoagulation in patients with mechanical prosthetic valves and intracranial haemorrhage. Intern Med J. 2011 Oct;41(10):750-4. doi: 10.1111/j.1445-5994.2011.02579.x.
- Results publication: PubMed 15804471Cahill RA, McGreal GT, Crowe BH, Ryan DA, Manning BJ, Cahill MR, Redmond HP. Duration of increased bleeding tendency after cessation of aspirin therapy. J Am Coll Surg. 2005 Apr;200(4):564-73; quiz A59-61. doi: 10.1016/j.jamcollsurg.2004.11.002.
- Results publication: PubMed 16969624Korinth MC. Low-dose aspirin before intracranial surgery--results of a survey among neurosurgeons in Germany. Acta Neurochir (Wien). 2006 Nov;148(11):1189-96; discussion 1196. doi: 10.1007/s00701-006-0868-4. Epub 2006 Sep 21.
- Individual participant dataSharing planned: No
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.
Shuo Wang study chair
Beijing Tiantan 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 Severe Spontaneous Intracranial Hemorrhage and Long-term Antiplatelet Treatment, run by Beijing Tiantan 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuo Wang (+86 13801180330, captain9858@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total mortality (time frame: From admission to 6 months after the occurrence primary hemorrhage). 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 NCT05975398, which also lists 27 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 10 Jul 2026.