Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

October 7, 2024 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Orthopedics Department of Peking University Third Hospital
  • Phone Number: 008618811597977
  • Email: 2411210441@pku.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with spinal disorders who come to Peking University Third Hospital for treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
if the patients have postoperative symptomatic spinal epidural hematoma
Time Frame: within 2 weeks after spinal surgery

patients with symptoms as below：

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUTH00238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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