The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury

NCT ID: NCT07024381

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2024-09-01

Brief Summary

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This study adopts a retrospective design, continuously including patients with TBI treated at the Emergency Trauma Center of the First Affiliated Hospital of Suzhou University from May 2017 to September 2024. Investigators used the hospital's electronic medical record system to collect clinical data. The patients' age, gender, history of diabetes, history of hypertension, medication history, mechanism of injury, mean arterial pressure, Glasgow Coma Scale, and other information were recorded upon emergency admission. Laboratory indicators included white blood cell count, hemoglobin (HB) levels, platelet count, C-reactive protein, international normalized ratio (INR), and albumin. Myocardial injury markers included alpha-hydroxybutyrate dehydrogenase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, creatine kinase-MB (CK-MB), myoglobin, NT-pro BNP, and high-sensitivity troponin T. Additionally, continuous ECG monitoring was conducted for 24 hours after admission.

Detailed Description

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This study adopts a retrospective design, continuously including patients with TBI treated at the Emergency Trauma Center of the First Affiliated Hospital of Suzhou University from May 2017 to September 2024. Investigators used the hospital's electronic medical record system to collect clinical data. The patients' age, gender, history of diabetes, history of hypertension, medication history, mechanism of injury, mean arterial pressure, Glasgow Coma Scale, and other information were recorded upon emergency admission. Laboratory indicators included white blood cell count, hemoglobin (HB) levels, platelet count, C-reactive protein, international normalized ratio (INR), and albumin. Myocardial injury markers included alpha-hydroxybutyrate dehydrogenase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, creatine kinase-MB (CK-MB), myoglobin, NT-pro BNP, and high-sensitivity troponin T. Additionally, continuous ECG monitoring was conducted for 24 hours after admission.

Conditions

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TBI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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This study takes the GOS score at 6 months follow-up after patient discharge as the primary endpoint

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. clinical diagnosis of traumatic brain injury
2. GCS score between 9-15;
3. Head and neck simplified injury score (AIS) ≤4;

Exclusion Criteria

1. clinical diagnosis of tumors, active infections, or hematologic diseases;
2. those who have received treatment with beta-blockers, anticholinergic drugs, or anticoagulants within 6 months before admission;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peng Yang

OTHER

Sponsor Role lead

Responsible Party

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Peng Yang

phd.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Emergency Medicine,the First Affiliated Hospital of Soochow University.

Suzhou, Jiangsu, China

Site Status

Countries

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China

References

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Wu C, Liu L, Chen D, Zhu W, Xu F, Yang P. The Predictive Value of Heart Rate Variability for the Prognosis of Patients with Mild to Moderate Traumatic Brain Injury. Neurol Ther. 2025 Oct;14(5):1889-1901. doi: 10.1007/s40120-025-00792-0. Epub 2025 Jul 4.

Reference Type DERIVED
PMID: 40614040 (View on PubMed)

Other Identifiers

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2024-712

Identifier Type: -

Identifier Source: org_study_id

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