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| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
| Beijing Shuyi Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Guangzhou Red Cross Hospital |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency neurosurgery | Procedure | Surgical evacuation for intracerebral hemorrhage | ||
| Conservative treatment | Procedure | Standard treatment for intracerebral hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Total mortality | From admission to 6 months after the occurrence primary hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative intracranial bleeding | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuo Wang | Contact | +86 13801180330 | captain9858@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuo Wang | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30319113 | Result | 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. | |
| 26022637 | Result | 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. |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| Beijing Pinggu District Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Wuxi No. 2 People's Hospital | OTHER |
| Dezhou People's Hospital | OTHER |
| Binzhou People's Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Anxi County Hospital | UNKNOWN |
| Datong People's Hospital | UNKNOWN |
| Shijiazhuang Third Hospital | UNKNOWN |
| Qingyuan People's Hospital | OTHER |
| Jingzhou Central Hospital | OTHER |
| Jiuquan City People's Hospital | UNKNOWN |
| Zhoukou People's Hospital | UNKNOWN |
| Jincheng People's Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Xinyu People's Hospital | UNKNOWN |
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| 30, 90, 180, and 365 days after surgery |
| 20651276 | Result | Morgenstern 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. |
| 23726393 | Result | Mendelow 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. |
| 30617144 | Result | Goyal 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. |
| 19236490 | Result | Wang 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. |
| 29730105 | Result | Xia 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. |
| 17509483 | Result | Lovelock 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. |
| 23718166 | Result | Baron 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. |
| 22435901 | Result | Krittalak 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. |
| 15804471 | Result | Cahill 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. |
| 16969624 | Result | Korinth 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. |
| 30193947 | Result | de 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. |
| 18574269 | Result | Douketis 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. |
| 18575419 | Result | Douketis JD, Bakhsh E. Perioperative management of antithrombotic therapy. Pol Arch Med Wewn. 2008 Apr;118(4):201-8. |
| 9574641 | Result | Wijdicks EF, Schievink WI, Brown RD, Mullany CJ. The dilemma of discontinuation of anticoagulation therapy for patients with intracranial hemorrhage and mechanical heart valves. Neurosurgery. 1998 Apr;42(4):769-73. doi: 10.1097/00006123-199804000-00053. |
| 15784122 | Result | Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x. |
| 19789037 | Result | Kashuk JL, Moore EE, Sabel A, Barnett C, Haenel J, Le T, Pezold M, Lawrence J, Biffl WL, Cothren CC, Johnson JL. Rapid thrombelastography (r-TEG) identifies hypercoagulability and predicts thromboembolic events in surgical patients. Surgery. 2009 Oct;146(4):764-72; discussion 772-4. doi: 10.1016/j.surg.2009.06.054. |
| 19443791 | Result | Naidech AM, Jovanovic B, Liebling S, Garg RK, Bassin SL, Bendok BR, Bernstein RA, Alberts MJ, Batjer HH. Reduced platelet activity is associated with early clot growth and worse 3-month outcome after intracerebral hemorrhage. Stroke. 2009 Jul;40(7):2398-401. doi: 10.1161/STROKEAHA.109.550939. Epub 2009 May 14. |
| 18843607 | Result | Prasad K, Mendelow AD, Gregson B. Surgery for primary supratentorial intracerebral haemorrhage. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD000200. doi: 10.1002/14651858.CD000200.pub2. |
| 28578111 | Result | Li Y, Yang R, Li Z, Yang Y, Tian B, Zhang X, Wang B, Lu D, Guo S, Man M, Yang Y, Luo T, Gao G, Li L. Surgical Evacuation of Spontaneous Supratentorial Lobar Intracerebral Hemorrhage: Comparison of Safety and Efficacy of Stereotactic Aspiration, Endoscopic Surgery, and Craniotomy. World Neurosurg. 2017 Sep;105:332-340. doi: 10.1016/j.wneu.2017.05.134. Epub 2017 May 31. |
| 29129764 | Result | Yao Z, Ma L, You C, He M. Decompressive Craniectomy for Spontaneous Intracerebral Hemorrhage: A Systematic Review and Meta-analysis. World Neurosurg. 2018 Feb;110:121-128. doi: 10.1016/j.wneu.2017.10.167. Epub 2017 Nov 10. |
| 26986116 | Result | Zheng J, Li H, Zhao HX, Guo R, Lin S, Dong W, Ma L, Fang Y, Tian M, Liu M, You C. Surgery for Patients With Spontaneous Deep Supratentorial Intracerebral Hemorrhage: A Retrospective Case-Control Study Using Propensity Score Matching. Medicine (Baltimore). 2016 Mar;95(11):e3024. doi: 10.1097/MD.0000000000003024. |
| 26690758 | Result | Stein M, Misselwitz B, Hamann GF, Kolodziej M, Reinges MH, Uhl E. In-hospital mortality after pre-treatment with antiplatelet agents or oral anticoagulants and hematoma evacuation of intracerebral hematomas. J Clin Neurosci. 2016 Apr;26:42-5. doi: 10.1016/j.jocn.2015.05.069. Epub 2015 Dec 11. |
| 24379098 | Result | Khoo KF, Lepas B. Summary of evidence-based guideline: Periprocedural management of antithrombotic medications in patients with ischemic cerebrovascular disease: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014 Jan 7;82(1):95. doi: 10.1212/01.NEUROLOGY.0000437348.92583.18. No abstract available. |
| 29341793 | Result | Holzmacher JL, Reynolds C, Patel M, Maluso P, Holland S, Gamsky N, Moore H, Acquista E, Carrick M, Amdur R, Hancock H, Metzler M, Dunn J, Sarani B. Platelet transfusion does not improve outcomes in patients with brain injury on antiplatelet therapy. Brain Inj. 2018;32(3):325-330. doi: 10.1080/02699052.2018.1425804. Epub 2018 Jan 17. |
| 13129878 | Result | Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD; Study of Medical Testing for Cataract Surgery Team. Risks and benefits of anticoagulant and antiplatelet medication use before cataract surgery. Ophthalmology. 2003 Sep;110(9):1784-8. doi: 10.1016/S0161-6420(03)00785-1. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |