NCT05696639

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5.7 years

First QC Date

January 13, 2023

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • brain swelling

    grading of brain swelling

    2 weeks

Study Arms (2)

Undeveloped venous group

patients with undeveloped cerebral venous

Procedure: Aneurysm embolization

Well Developed venous group

patients with well-developed cerebral venous

Procedure: Aneurysm embolization

Interventions

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

Undeveloped venous groupWell Developed venous group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an anterior communicating aneurysmal subarachnoid hemorrhage between January 2017 and December 2022 who underwent aneurysm embolization surgery, excluding patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors.

You may qualify if:

  • patients with anterior communicating aneurysm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Baoan People's Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (1)

  • Zhang Y, Hu J. Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid hemorrhage: a randomized controlled clinical trial protocol. Trials. 2023 Jul 8;24(1):447. doi: 10.1186/s13063-023-07493-9.

MeSH Terms

Conditions

AneurysmSubarachnoid HemorrhageBrain Edema

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JIangang Hu, Phd

    The People Hospital of Shenzhen Baoan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

April 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 30, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations