China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Complications Clinical Trial

Official title:

China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975398
• Other study ID #: KY2019-096-02-1
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Beijing Tiantan Hospital
• Contact: Shuo Wang
• Phone: +86 13801180330
• Email: captain9858[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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 SSICH 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. Study Design: 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. Objective: In this study, investigators will estimate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Complications
• Emergencies
• Emergency Surgery
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Procedure:
• Emergency neurosurgery
Surgical evacuation for intracerebral hemorrhage
• Conservative treatment
Standard treatment for intracerebral hemorrhage

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Binzhou People's Hospital, Dezhou People's Hospital, Guangzhou Red Cross Hospital, Wuxi No. 2 People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (27)

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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( — View Citation

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 Se — View Citation

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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. — View Citation

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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 — View Citation

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( — View Citation

Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x. — View Citation

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. La — View Citation

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. Guideli — View Citation

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):2398-4 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 Neuros — View Citation

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. — View Citation

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). — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality		From admission to 6 months after the occurrence primary hemorrhage
Secondary	Postoperative intracranial bleeding		Within one week after surgery