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Completed

NCT Number: NCT07024381

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

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.

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Key information

Conditions

TBI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Suzhou, Jiangsu, 215100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Glasgow Outcome Score

    Time frame: 6 months after discharge

    Glasgow Outcome Score

    • Dead: As a direct result of brain trauma, or due to secondary complications, or other complications
    • Vegetative State: Patients who remain unresponsive and speechless…. 3, Severe Disability: The patient is conscious but needs the assistance of another person for some activities of daily living every day 4, Moderate Disability: Such a patient can look after himself at home, get out and about to the shops, and travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible because of either physical or mental deficit 5, Good Recovery: This indicates the capacity to resume normal occupational and social activities, although minor physical or mental deficits may exist. Social outcomes should be included in the assessment here, such as leisure activities and family relationships.
  2. Standard deviation of all NN intervals(SDNN)

    Time frame: Day 1 post-TBI.

    This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) present within the heart rhythm. It is a time domain measure of heart rate variability(HRV), and it serves as a marker of overall adaptability of the nervous system.

  3. The average of all 5-minute standard deviations of NN intervals across a 24-hour period (SDNN index)

    Time frame: day 1 post TBI

    The average of all 5-minute standard deviations of NN intervals across 24 hours (SDNN index). Reflects combined parasympathetic and sympathetic modulation

  4. The root mean square of successive differences between NN intervals (RMSSD)

    Time frame: Day 1 post-TBI

    The Root Mean Square of Successive Differences between NN intervals (RMSSD) quantifies the variability in time intervals between consecutive normal heartbeats (NN intervals) on an electrocardiogram (ECG). Reflects parasympathetic (vagal) tone, as it captures rapid, beat-to-beat changes in heart rate mediated by the autonomic nervous system. A higher RMSSD indicates greater HRV and adaptability of the cardiovascular system, often associated with better stress resilience and recovery.

  5. The proportion of consecutive NN intervals differing by over 50 ms, relative to the total number of NN intervals (pNN50)

    Time frame: day 1 post-TBI

    A higher pNN50 indicates greater parasympathetic dominance. A lower pNN50 suggests reduced vagal tone, common in stress, aging, or pathologies.

  6. Triangle index

    Time frame: day 1 post TBI

    The Triangle Index is a global measure of heart rate variability derived from the geometric properties of an NN interval histogram. A higher value indicates greater overall HRV, reflecting healthy autonomic nervous system function.

  7. HRV High Frequency Power

    Time frame: Day 1 post-TBI

    Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded on day 1 of TBI

  8. HRV low frequency power

    Time frame: Day 1 post- TBI

    Low-frequency (LF) power (typically 0.04-0.15 Hz) is a spectral component of HRV reflecting mixed sympathetic and parasympathetic influences on heart rate, with potential contributions from baroreflex activity.

  9. HRV very low frequency power

    Time frame: Day 1 post- TBI

    VLF (Very-Low-Frequency) power is a spectral component of heart rate variability (HRV) in the 0.0033-0.04 Hz range (or sometimes <0.05 Hz). VLF is linked to long-term autonomic and neurohormonal control.

Secondary outcomes

  1. Glasgow Coma Scale

    Time frame: On Day 1 after TBI onset

    Its values range from 3 to 15. 13 to 15: Mild traumatic brain injury (mTBI). 9 to 12: Moderate TBI.3 to 8: Severe TBI.

  2. Hypertension history

    Time frame: On Day 1 after TBI onset

  3. Diabetes history

    Time frame: On Day 1 after TBI onset

  4. Age

    Time frame: Baseline

  5. White Blood Cell Count

    Time frame: On Day 1 after TBI onset

    White Blood Cell (WBC) count refers to the measurement of the total number of white blood cells (leukocytes) per microliter (µL) or cubic millimeter (mm³) of blood. These cells are a crucial component of the immune system, playing essential roles in defending the body against infections, foreign substances, and diseases.

  6. Hemoglobin

    Time frame: On Day 1 after TBI onset

    Hemoglobin (Hb or Hgb) is an iron-containing protein found in red blood cells (RBCs) that binds oxygen in the lungs and delivers it to tissues throughout the body while also transporting carbon dioxide back to the lungs for exhalation.

  7. Platelets (thrombocytes)

    Time frame: On Day 1 after TBI onset

    Platelets (thrombocytes) are small, colorless cell fragments in the blood that play a crucial role in clotting and stopping bleeding. The platelet count (PLT) measures the number of platelets per microliter (μL) of blood.

  8. C-Reactive Protein (CRP)

    Time frame: On Day 1 after TBI onset

    C-reactive protein (CRP) is a liver-produced protein that increases rapidly in response to inflammation, infection, or tissue damage. It is a key acute-phase reactant used to detect and monitor inflammatory conditions.

  9. International Normalized Ratio

    Time frame: On Day 1 after TBI onset

  10. Albumin

    Time frame: On Day 1 after TBI onset

  11. Alpha-Hydroxybutyrate Dehydrogenase

    Time frame: On Day 1 after TBI onset

  12. Creatine Kinase

    Time frame: On Day 1 after TBI onset

  13. Lactate Dehydrogenase

    Time frame: On Day 1 after TBI onset

  14. Aspartate Aminotransferase

    Time frame: On Day 1 after TBI onset

  15. Creatine Kinase-MB

    Time frame: On Day 1 after TBI onset

  16. Myoglobin

    Time frame: On Day 1 after TBI onset

  17. N-Terminal pro-BNP

    Time frame: On Day 1 after TBI onset

  18. High-Sensitivity Troponin T

    Time frame: On Day 1 after TBI onset

Sponsors and collaborators

Lead sponsor

Peng Yang

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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