Clinical trial NCT07024381: The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury
Official title: The Predictive Value of Heart Rate Variability for the Prognosis of Patients With Mild to Moderate Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TBI
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Glasgow Outcome Score
timeFrame: 6 months after discharge
measure: Standard deviation of all NN intervals（SDNN）
timeFrame: Day 1 post-TBI.
measure: The average of all 5-minute standard deviations of NN intervals across a 24-hour period (SDNN index)
timeFrame: day 1 post TBI
measure: The root mean square of successive differences between NN intervals (RMSSD)
timeFrame: Day 1 post-TBI
measure: The proportion of consecutive NN intervals differing by over 50 ms, relative to the total number of NN intervals (pNN50)
timeFrame: day 1 post-TBI
measure: Triangle index
timeFrame: day 1 post TBI
measure: HRV High Frequency Power
timeFrame: Day 1 post-TBI
measure: HRV low frequency power
timeFrame: Day 1 post- TBI
measure: HRV very low frequency power
timeFrame: Day 1 post- TBI
Secondary outcomes:
measure: Glasgow Coma Scale
timeFrame: On Day 1 after TBI onset
measure: Hypertension history
timeFrame: On Day 1 after TBI onset
measure: Diabetes history
timeFrame: On Day 1 after TBI onset
measure: Age
timeFrame: Baseline
measure: White Blood Cell Count
timeFrame: On Day 1 after TBI onset
measure: Hemoglobin
timeFrame: On Day 1 after TBI onset
measure: Platelets (thrombocytes)
timeFrame: On Day 1 after TBI onset
measure: C-Reactive Protein (CRP)
timeFrame: On Day 1 after TBI onset
measure: International Normalized Ratio
timeFrame: On Day 1 after TBI onset
measure: Albumin
timeFrame: On Day 1 after TBI onset
measure: Alpha-Hydroxybutyrate Dehydrogenase
timeFrame: On Day 1 after TBI onset
measure: Creatine Kinase
timeFrame: On Day 1 after TBI onset
measure: Lactate Dehydrogenase
timeFrame: On Day 1 after TBI onset
measure: Aspartate Aminotransferase
timeFrame: On Day 1 after TBI onset
measure: Creatine Kinase-MB
timeFrame: On Day 1 after TBI onset
measure: Myoglobin
timeFrame: On Day 1 after TBI onset
measure: N-Terminal pro-BNP
timeFrame: On Day 1 after TBI onset
measure: High-Sensitivity Troponin T
timeFrame: On Day 1 after TBI onset
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Department of Emergency Medicine，the First Affiliated Hospital of Soochow University.
state: Jiangsu
Study officials:
References: