Department of Emergency Medicine,the First Affiliated Hospital of Soochow University.
Suzhou, Jiangsu, 215100, China
NCT Number: NCT07024381
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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All sexes
Observational
Suzhou, Jiangsu, 215100, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months after discharge
Glasgow Outcome Score
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.
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
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.
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.
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.
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
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.
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.
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.
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: Baseline
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.
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.
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.
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.
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Time frame: On Day 1 after TBI onset
Peng Yang
Other
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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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