Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma

NCT ID: NCT06633848

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Epidural Hematoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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spinal surgery

spinal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Orthopedics Department of Peking University Third Hospital

Role: CONTACT

008618811597977

References

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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.

Reference Type BACKGROUND
PMID: 10688055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24316117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35819540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36260132 (View on PubMed)

Other Identifiers

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PekingUTH00238

Identifier Type: -

Identifier Source: org_study_id

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