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

NCT07024381 | Completed

• 1 other identifier: 2024-712
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

TBI

Outcome Measures

Primary Outcomes (9)

• Glasgow Outcome Score

  Glasgow Outcome Score 1. Dead: As a direct result of brain trauma, or due to secondary complications, or other complications 2. 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.

  6 months after discharge

• Standard deviation of all NN intervals（SDNN）

  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.

  Day 1 post-TBI.

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

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

  day 1 post TBI

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

  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.

  Day 1 post-TBI

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

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

  day 1 post-TBI

• Triangle index

  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.

  day 1 post TBI

• HRV High Frequency Power

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

  Day 1 post-TBI

• HRV low frequency power

  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.

  Day 1 post- TBI

• HRV very low frequency power

  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.

  Day 1 post- TBI

Secondary Outcomes (18)

• Glasgow Coma Scale

  On Day 1 after TBI onset

• Hypertension history

  On Day 1 after TBI onset

• Diabetes history

  On Day 1 after TBI onset

• Age

  Baseline

• White Blood Cell Count

  On Day 1 after TBI onset

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild-to-moderate TBI patients admitted to our emergency department (May 2017- Sep 2024) were diagnosed by CT, symptoms, history, and physical examination.

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peng Yang: lead

Study Sites (1)

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

Suzhou, Jiangsu, 215100, China

Location

Related Publications (1)

• 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.

  PMID: 40614040 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phd.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 17, 2025
• Study Start: May 1, 2017
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CN (1)