TBINCT07024381
The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury
An observational study of TBI, run by Peng Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- clinical diagnosis of traumatic brain injury
- GCS score between 9-15;
- Head and neck simplified injury score (AIS) ≤4;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Emergency Medicine，the First Affiliated Hospital of Soochow University.
Suzhou, Jiangsu, 215100
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.
Read the 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.
- Conditions
- TBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| This study takes the GOS score at 6 months follow-up after patient discharge as the primary endpoint | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Score
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 1 post- TBI
Secondary outcomes (18)
Glasgow Coma Scale
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.
Measured: On Day 1 after TBI onset
Hypertension history
Measured: On Day 1 after TBI onset
Diabetes history
Measured: On Day 1 after TBI onset
Age
Measured: Baseline
White Blood Cell Count
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.
Measured: On Day 1 after TBI onset
Hemoglobin
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.
Measured: On Day 1 after TBI onset
Platelets (thrombocytes)
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.
Measured: On Day 1 after TBI onset
C-Reactive Protein (CRP)
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.
Measured: On Day 1 after TBI onset
International Normalized Ratio
Measured: On Day 1 after TBI onset
Albumin
Measured: On Day 1 after TBI onset
Alpha-Hydroxybutyrate Dehydrogenase
Measured: On Day 1 after TBI onset
Creatine Kinase
Measured: On Day 1 after TBI onset
Lactate Dehydrogenase
Measured: On Day 1 after TBI onset
Aspartate Aminotransferase
Measured: On Day 1 after TBI onset
Creatine Kinase-MB
Measured: On Day 1 after TBI onset
Myoglobin
Measured: On Day 1 after TBI onset
N-Terminal pro-BNP
Measured: On Day 1 after TBI onset
High-Sensitivity Troponin T
Measured: On Day 1 after TBI onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 May 2017
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Yang, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024381
- Sponsor's protocol ID
- 2024-712
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publish in the form of an academic paper
Publications
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.
PubMed 40614040
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07024381
- Acronym / sponsor ID
- 2024-712
- Conditions
- TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Peng YangUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This study takes the GOS score at 6 months follow-up after patient discharge as the primary endpoint | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- clinical diagnosis of traumatic brain injury
- GCS score between 9-15;
- Head and neck simplified injury score (AIS) ≤4;
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Score
Time frame: 6 months after discharge
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.
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.
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
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.
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.
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.
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
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.
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.
18 secondary outcomes
Glasgow Coma Scale
Time frame: On Day 1 after TBI onset
Hypertension history
Time frame: On Day 1 after TBI onset
Diabetes history
Time frame: On Day 1 after TBI onset
Age
Time frame: Baseline
White Blood Cell Count
Time frame: On Day 1 after TBI onset
Hemoglobin
Time frame: On Day 1 after TBI onset
Platelets (thrombocytes)
Time frame: On Day 1 after TBI onset
C-Reactive Protein (CRP)
Time frame: On Day 1 after TBI onset
International Normalized Ratio
Time frame: On Day 1 after TBI onset
Albumin
Time frame: On Day 1 after TBI onset
Alpha-Hydroxybutyrate Dehydrogenase
Time frame: On Day 1 after TBI onset
Creatine Kinase
Time frame: On Day 1 after TBI onset
Lactate Dehydrogenase
Time frame: On Day 1 after TBI onset
Aspartate Aminotransferase
Time frame: On Day 1 after TBI onset
Creatine Kinase-MB
Time frame: On Day 1 after TBI onset
Myoglobin
Time frame: On Day 1 after TBI onset
N-Terminal pro-BNP
Time frame: On Day 1 after TBI onset
High-Sensitivity Troponin T
Time frame: On Day 1 after TBI onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 40614040Wu 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.
- Individual participant dataSharing planned: Undecided. Publish in the form of an academic paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI, run by Peng Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Score (time frame: 6 months after discharge). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.