Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

NCT06633848 | Not Yet Recruiting

• 1 other identifier: PekingUTH00238
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Epidural Hematoma

Keywords

artificial intelligence algorithm; clinical prediction model; postoperative symptomatic spinal epidural hematoma

Outcome Measures

Primary Outcomes (1)

• if the patients have postoperative symptomatic spinal epidural hematoma

  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

Interventions

spinal surgery PROCEDURE

spinal surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Related Publications (4)

• Negulyaev YA, Markwardt F. Block by extracellular Mg2+ of single human purinergic P2X4 receptor channels expressed in human embryonic kidney cells. Neurosci Lett. 2000 Feb 4;279(3):165-8. doi: 10.1016/s0304-3940(99)00976-3.

  PMID: 10688055 BACKGROUND

• Goldstein CL, Bains I, Hurlbert RJ. Symptomatic spinal epidural hematoma after posterior cervical surgery: incidence and risk factors. Spine J. 2015 Jun 1;15(6):1179-87. doi: 10.1016/j.spinee.2013.11.043. Epub 2013 Dec 6.

  PMID: 24316117 BACKGROUND

• Xia T, Zhou F, Chu H, Tan LA, Sun Y, Wang S. Incidence and risk factors of postoperative symptomatic spinal epidural hematoma in cervical spine surgery: a single center, retrospective study of 18,220 patients. Eur Spine J. 2022 Oct;31(10):2753-2760. doi: 10.1007/s00586-022-07301-z. Epub 2022 Jul 10.

  PMID: 35819540 BACKGROUND

• Chen Q, Zhong X, Liu W, Wong C, He Q, Chen Y. Incidence of postoperative symptomatic spinal epidural hematoma requiring surgical evacuation: a systematic review and meta-analysis. Eur Spine J. 2022 Dec;31(12):3274-3285. doi: 10.1007/s00586-022-07421-6. Epub 2022 Oct 19.

  PMID: 36260132 BACKGROUND

MeSH Terms

Conditions

Hematoma, Epidural, Spinal

Condition Hierarchy (Ancestors)

Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Orthopedics Department of Peking University Third Hospital

CONTACT

008618811597977; 2411210441@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 9, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share