Severe Spontaneous Intracranial HemorrhageNCT05766865
Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
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: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 450 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2019to 30 Nov 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.
Who may be able to join
- (1) 18-75 years old;
- (2) non-traumatic intracerebral hemorrhage;
- (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume > 30 ml, infratentorial bleeding volume > 10 ml, midline shift > 1 cm, or large intraventricular hematoma;
- (4) Glasgow coma score (GCS) < 13;
- (5) family members agree to provide an informed written consent.
Who cannot join
- (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage;
- (2) hemorrhagic transformation of cerebral infarction;
- (3) hemorrhage caused by venous thrombosis;
- (4) patients with severe coagulation disorder, e.g., hemophilia;
- (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
- (6) patients receiving other anticoagulation medications (vitamin K antagonist and new oral anticoagulants);
- (7) patients not on LOAPT who receive conservative treatment;
- (8) the patients who died before or on arriving at the hospital and within a short period (6 h) after admission.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
About this study
Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.
Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSIC H patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.
Read more
Results: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.
Conclusions: In this study, we will investigate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.
- Conditions
- Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery, Complications
- Being tested
- Emergency neurosurgery, Conservative treatment
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 (1)
Postoperative intracranial bleeding
Measured: Within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start10 Jul 2019
- Primary completion31 May 2022
- Study completion30 Nov 2022
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
- 450 participants (actual)
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
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766865
- Sponsor's protocol ID
- KY2019-096-02
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2022
- Last updated
- 13 Mar 2023
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
- ClinicalTrials.gov ID
- NCT05766865
- Acronym / sponsor ID
- KY2019-096-02
- Conditions
- Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment, Emergency Surgery, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- 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
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Mar 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: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.
Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSIC H patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.
Results: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.
Conclusions: In this study, we will investigate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.
Key inclusion criteria (5 listed)
- (1) 18-75 years old;
- (2) non-traumatic intracerebral hemorrhage;
- (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume > 30 ml, infratentorial bleeding volume > 10 ml, midline shift > 1 cm, or large intraventricular hematoma;
- (4) Glasgow coma score (GCS) < 13;
- (5) family members agree to provide an informed written consent.
Key exclusion criteria (8 listed)
- (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage;
- (2) hemorrhagic transformation of cerebral infarction;
- (3) hemorrhage caused by venous thrombosis;
- (4) patients with severe coagulation disorder, e.g., hemophilia;
- (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
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
1 secondary outcome
Postoperative intracranial bleeding
Time frame: Within one week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- 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
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Severe Spontaneous Intracranial Hemorrhage, Long-term Antiplatelet Treatment
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.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 13 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT05766865, 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 13 Mar 2023.