Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

The goal of this observational study is to establish a clinical prediction model based on artificial intelligence algorithms for patients with postoperative symptomatic spinal epidural hematoma(PSSEH) after spinal surgery. The investigators will collect the features of 2000 patients as the training set to train the models using AI algorithms, then recruit a prospective cohort of 2000 patients to test if the trained model is precise and consistent to predict the occurrence of PSSEH as well as to find out whether there is any new risk factor of PSSEH.

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Key information

Conditions

Spinal Epidural Hematoma Hematoma Hematoma, Epidural, Spinal Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

Firstly, the investigators plan to collect the features of 2000 patients who received spinal surgery at Peking University Third Hospital from January 2014 to December 2024, including those with PSSEH and the controls, as the training set to build up a prediction model based on multiple AI algorithms. Then, the investigators will choose the optimal model through comparing various features, assessing the robustness of the model quantitatively using k-fold cross validation and exploring the influence of all features on the output of the final model by means such as SHAP. Lastly, the investigators will recruit a prospective cohort of approximately 2000 patients who receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital and collect the same features as the training set to test if the trained prediction model is precise and consistent to predict the occurrence of PSSEH and whether there is any feature , undiscovered before, that is strongly related to PSSEH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients who will receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital

Exclusion criteria

patients with a history of lumbar trauma before admission;
patients who suffer from malignant tumor;
patients with systemic infection;
patients who quit the study midway

Treatment and study plan

spinal surgery

Procedure

spinal surgery

Primary outcomes

if the patients have postoperative symptomatic spinal epidural hematoma

Time frame: within 2 weeks after spinal surgery
patients with symptoms as below：
- Persistent wound bleeding;
- Exacerbation of wound pain;
- Radicular symptoms-severe low back pain, shoulder and neck pain;
- Motor dysfunction-limb muscle weakness, muscle atrophy;
- Sensory abnormalities-reduced or lost tactile sensation, pain, and temperature perception;
- pharyngeal discomfort, shortness of breath, and difficulty breathing;
- Urinary and bowel dysfunction-urinary retention, urinary incontinence, dysporia;
- Hematoma compressing the dura mater discovered during hematoma evacuation surgery;
- Suspected PSSEH based on the surgeon's assessment；
- Definitive diagnosis by MRI imaging;

Study contacts

Contact information is provided by the study sponsor or research team.

Orthopedics Department of Peking University Third Hospital

CONTACT

[email protected]

008618811597977

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Establishment of Artificial Intelligence Algorithms Based Clinical Prediction Model for Patients with Postoperative Symptomatic Spinal Epidural Hematoma After Spinal Surgery

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 9, 2024
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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