Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766865
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2022-11-23
Brief Title:
Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None