Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute

This is a retrospective, observational single-center study. The studies is to investigate the incidence of posterior epidural spinal hematoma(PSEH) and recognize the risk factors for it in a cohort of patients undergoing posterior thoracic surgery in isolation.

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Key information

Conditions

Spinal Epidural Hematoma Cerebrospinal Fluid Leak Craniocerebral Trauma Hematoma Hematoma, Epidural, Spinal Hemorrhage Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thoracic Surgery Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third hospital

Beijing, Beijing Municipality, 100191, China

About this study

The study enrolled patients from January 2010 to December 2019, patients who developed PSEH after posterior thoracic surgery and underwent the hematoma evacuation. For each PSEH patients, 2 or 3 controls who did not develop the PSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period were collected. The preoperative and intraoperative factors, blood pressure related factors and radiographic parameters were collected to identify possible risk factors by comparing between two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects satisfying the following criteria will be considered eligible for enrollment in this study:

Patient is ≥ 18 years and < 80 years of age;
Patient who received thoracic decompression surgery via posterior approach
Patient who diagnosed as symptomatic spinal epidural haematoma and received revision surgery.

Exclusion criteria

Thoracic spinal stenosis caused by trauma, tumor, infectious, deformity and other disease;
Symptomatic spinal epidural haematoma happened at cervicothoracic and thoracolumbar junction;
Initial surgeries were performed at other hospital;
Incomplete clinical data.

Treatment and study plan

Primary outcomes

Large local kyphosis angle

Time frame: 6 months

The local kyphosis angle was determined by the measurement of the Cobb angle. Large local kyphosis angle creates a narrow space between the paravertebral muscles and spinal cord, especially in muscles with edema after surgery. Large local kyphosis angle is considered as a risk factor for symptomatic spinal epidural hematoma
High occupying ratio of cross-sectional area

Time frame: 6 months

Severe compression on spinal epidural venous plexus lead to poor elasticity of the vessel wall and impedance of blood flow. As a result, dilatation of the spinal epidural venous plexus are more often in symptomatic spinal epidural haematoma patients, contributing to the development of haematoma. Therefore, high occupying ratio of cross-sectional area is considered as a risk factors for symptomatic spinal epidural hematoma.
Cerebrospinal fluid leakage

Time frame: 6 months

Cerebrospinal fluid leakage provides internal pressure for the dura and its own contents, and a small haematoma does not easily induce symptoms. It is the author's hypothesis that if cerebrospinal fluid leakage occurs intraoperatively, internal pressure loss, even in a small hematoma, can cause compression. Therefore, cerebrospinal fluid leakage are considered as a risk factor for symptomatic spinal epidural hematoma

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jul 14, 2021
Registry last updated: Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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