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Spinal Epidural HematomaNCT06633848

Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

An observational study of Spinal Epidural Hematoma, run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Spinal Epidural Hematoma
What is being tested?
spinal surgery
Type of treatment
Surgery or procedure
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Jan 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Orthopedics Department of Peking University Third Hospital contact

008618811597977

2411210441@pku.edu.cn

China1 site, 1 recruiting

  • Orthopaedic Department of Peking University Third Hospital

    Beijing, Haidian, 100191

    Yichen Zhang, 008618811597977, 2411210441@pku.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Being tested
spinal surgery
Keywords
artificial intelligence algorithm, clinical prediction model, postoperative symptomatic spinal epidural hematoma
Medical subject headings
Hematoma, Epidural, Spinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spinal surgeryProcedure or surgery

    spinal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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;

    Measured: within 2 weeks after spinal surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633848
Sponsor's protocol ID
PekingUTH00238
Status last verified
Oct 2026
First submitted
29 Sep 2024
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Epidural Hematoma, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Orthopedics Department of Peking University Third Hospital (008618811597977, 2411210441@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

if the patients have postoperative symptomatic spinal epidural hematoma (time frame: within 2 weeks after spinal surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633848, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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