Effect and Safety of Surgical Intervention for Severe Spo... | NCT05766865

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2019Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Nov 23, 2022

First Submission Date that Met QC Criteria

Mar 10, 2023

First Posted Date

Mar 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2023

Last Update Posted Date

Mar 13, 2023Actual

Name	Class
Beijing Chao Yang Hospital	OTHER
Beijing Shuyi Hospital	OTHER
Beijing Anzhen Hospital	OTHER
Guangzhou Red Cross Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Shuo Wang	Beijing Tiantan Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Capital Medical University Affiliated Beijing Tiantan Hospital		Beijing	Beijing Municipality		China

References Module

Citations

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.