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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.

Primary conditionInflammation(the registry's first term)UnverifiedIs this wrong?Inflammation is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

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

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 3 months later.
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

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03

In context

Inflammation Unverified

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 864 observational studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Browse Second Affiliated Hospital, School of Medicine, Zhejiang University studies →

Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
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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.

06

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Aug 2024, 24 months after the start.

Of 354 non-industry observational studies under Inflammation, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 85. This study's planned 24 months is below that.

Counting every sponsor, half of 370 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2023
First posted
Aug 24, 2023
StartActual
Aug 1, 2022
Primary completionEst.
Aug 1, 2024
CompletionEst.
Aug 1, 2024
Last update
Aug 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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