Bayysmcv: SMCV Assessment on Brain Swelling in Patients With SAH

Sponsor

Shenzhen Baoan District People's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05696639

Collaborator

(none)

198

Enrollment

Location

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Subarachnoid Hemorrhage Brain Swelling	Procedure: Aneurysm embolization

Detailed Description

Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (SAH).This study is a retrospective cohort aimed to predict the extent of brain swelling (BS). Cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. This study is a retrospective cohort analysis. Cerebral venous angiography (CVA) will be adopted and the superficial middle cerebral vein (SMCVs) will be evaluated.

Study Design

Study Type:

Observational

Actual Enrollment :

198 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Cerebral Venous Assessment on Brain Swelling in Patients With Aneurysm Subarachnoid Hemorrhage: Retrospective Cohort Study

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Undeveloped venous group patients with undeveloped cerebral venous	Procedure: Aneurysm embolization All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.
Well Developed venous group patients with well-developed cerebral venous	Procedure: Aneurysm embolization All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.

Arm

Intervention/Treatment

Undeveloped venous group

patients with undeveloped cerebral venous

Procedure: Aneurysm embolization

All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.

Well Developed venous group

patients with well-developed cerebral venous

Procedure: Aneurysm embolization

All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.

Outcome Measures

Primary Outcome Measures

brain swelling [2 weeks]
grading of brain swelling

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

patients with anterior communicating aneurysm

Exclusion Criteria:

Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen Baoan People's Hospital	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

Shenzhen Baoan District People's Hospital

Investigators

Study Director: JIangang Hu, Phd, The People Hospital of Shenzhen Baoan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenzhen Baoan District People's Hospital

ClinicalTrials.gov Identifier:

NCT05696639

Other Study ID Numbers:

BYL20220216

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Brain Edema

Aneurysm

Hemorrhage

Study Results

No Results Posted as of Jan 25, 2023