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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07024381
Enrollment
172
Registered
2025-06-17
Start date
2017-05-01
Completion date
2024-09-01
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI

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.

Detailed description

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.

Interventions

None listed

Sponsors

Peng Yang
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Glasgow Outcome Score6 months after dischargeGlasgow 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.
Standard deviation of all NN intervals(SDNN)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.
The average of all 5-minute standard deviations of NN intervals across a 24-hour period (SDNN index)day 1 post TBIThe average of all 5-minute standard deviations of NN intervals across 24 hours (SDNN index). Reflects combined parasympathetic and sympathetic modulation
The root mean square of successive differences between NN intervals (RMSSD)Day 1 post-TBIThe 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.
The proportion of consecutive NN intervals differing by over 50 ms, relative to the total number of NN intervals (pNN50)day 1 post-TBIA higher pNN50 indicates greater parasympathetic dominance. A lower pNN50 suggests reduced vagal tone, common in stress, aging, or pathologies.
Triangle indexday 1 post TBIThe 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.
HRV High Frequency PowerDay 1 post-TBIBaseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded on day 1 of TBI
HRV low frequency powerDay 1 post- TBILow-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.
HRV very low frequency powerDay 1 post- TBIVLF (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

MeasureTime frameDescription
AlbuminOn Day 1 after TBI onset
Alpha-Hydroxybutyrate DehydrogenaseOn Day 1 after TBI onset
Creatine KinaseOn Day 1 after TBI onset
Lactate DehydrogenaseOn Day 1 after TBI onset
Glasgow Coma ScaleOn Day 1 after TBI onsetIts values range from 3 to 15. 13 to 15: Mild traumatic brain injury (mTBI). 9 to 12: Moderate TBI.3 to 8: Severe TBI.
Creatine Kinase-MBOn Day 1 after TBI onset
MyoglobinOn Day 1 after TBI onset
N-Terminal pro-BNPOn Day 1 after TBI onset
High-Sensitivity Troponin TOn Day 1 after TBI onset
Aspartate AminotransferaseOn Day 1 after TBI onset
Hypertension historyOn Day 1 after TBI onset
Diabetes historyOn Day 1 after TBI onset
AgeBaseline
White Blood Cell CountOn Day 1 after TBI onsetWhite 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.
HemoglobinOn Day 1 after TBI onsetHemoglobin (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.
Platelets (thrombocytes)On Day 1 after TBI onsetPlatelets (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.
C-Reactive Protein (CRP)On Day 1 after TBI onsetC-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.
International Normalized RatioOn Day 1 after TBI onset

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026