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RecruitingNCT06633848Updated Oct 22, 2026

Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

An observational study in Spinal Epidural Hematoma, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Updated Oct 22, 2026Now RecruitingFirst site in China+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spinal Epidural Hematoma

Keywords

  • artificial intelligence algorithm
  • clinical prediction model
  • postoperative symptomatic spinal epidural hematoma
03

In context

Hematoma, Epidural, Spinal

20 studies on the registry are indexed under Hematoma, Epidural, Spinal; 5 are open to participants now.

Browse Hematoma, Epidural, Spinal studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Browse Peking University Third Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • Procedurespinal surgery

    spinal surgery

06

What researchers measure

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;

    Time frame: within 2 weeks after spinal surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 10688055 ↗
  • 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. PubMed 24316117 ↗
  • 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. PubMed 35819540 ↗
  • 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. PubMed 36260132 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2024
First posted
Oct 9, 2024
StartActual
Jan 1, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
1 site added — first site in China
Show site
  • Orthopaedic Department of Peking University Third Hospital · Beijing, China
Oct 22, 2026
Eligibility
Revised
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in China
    Show site
    • Orthopaedic Department of Peking University Third Hospital · Beijing, China
    Eligibility Revised
    + 5 other changes: identifiers, verification date, date precision, oversight details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06633848
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Oct 9, 2024
Start date
Jan 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 22, 2026

Study contacts

Orthopedics Department of Peking University Third Hospital
Contact
2411210441@pku.edu.cn
008618811597977

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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