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RecruitingNCT06009016Updated Aug 24, 2023

Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

An observational study in Inflammation, Coagulation and Hemorrhagic Disorders and Cerebral Edema, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for predicting persistent cerebral edema after subarachnoid hemorrhage

02

Conditions studied

  • Inflammation
  • Coagulation and Hemorrhagic Disorders
  • Cerebral Edema
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified Fisher Scale 3-4, with a confirmed radiographic diagnosis. Age range from 20-80.

Inclusion criteria

  • Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified Fisher Scale 3-4, with a confirmed radiographic diagnosis.

Exclusion criteria

Exclusion Criteria:

  • Angiogram-negative patients, patients with a history of trauma or previous brain injury (stroke, hemorrhage, surgery et al. which left associated chronic changes on CT), arteriovenous malformation, radiological data lost, accompany with serious comorbidities before subarachnoid hemorrhage onset (such as coagulation defects, uncontrollable hypertension, and arrhythmia et.al.), initial radiological data performed more than 3 days after SAH onset
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testInflammatory factors and coagulation factors level in cerebrospinal fluid after subarachnoid hemorrhage

    Inflammatory factors and coagulation factors level in cerebrospinal fluid will be tested by ELISA kits.

05

What researchers measure

Primary outcomes

  1. Cerebral edema after subarachnoid hemorrhage

    Cerebral edema after subarachnoid hemorrhage will be determined by the SEBES score. SEBES 0-2 is mild edema; SEBES 3-4 is severe edema.

    Time frame: At 3 and 7days after SAH onset

  2. Outcome at 3 months after subarachnoid hemorrhage

    Outcome will be determined by the modified Rankin Score (mRS). mRS 0-2 is favorable outcome; mRS3-5 is poor outcome.

    Time frame: 3 months after subarachnoid hemorrhage

06

Study locations

1 of 1 sites recruiting
  • Second affiliated hospital of Zhejiang University, School of Medicine
    Hangzhou, Zhejiang 310000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06009016
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Yuanjian Fang (Second Affiliated Hospital, School of Medicine, Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Principal investigator
First posted
Aug 24, 2023
Start date
Aug 1, 2022
Primary completion
Aug 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Aug 24, 2023

Study contacts

Yuanjian Fang, M.D
Contact
sandman0506@zju.edu.cn
86-18768109541
Sheng Chen, M.D
Contact
saintchan@zju.edu.cn
86-13645814323

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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