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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961424
• Other study ID #: M2020006
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 18, 2021
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

1. Patient is = 18 years and < 80 years of age;

2. Patient who received thoracic decompression surgery via posterior approach

3. Patient who diagnosed as symptomatic spinal epidural haematoma and received revision surgery.

Exclusion Criteria:

1. Thoracic spinal stenosis caused by trauma, tumor, infectious, deformity and other disease;

2. Symptomatic spinal epidural haematoma happened at cervicothoracic and thoracolumbar junction;

3. Initial surgeries were performed at other hospital;

4. Incomplete clinical data.

Related Conditions & MeSH terms

• Hematoma
• Thoracic Surgery

Locations

Country	Name	City	State
China	Peking University Third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

Amiri AR, Fouyas IP, Cro S, Casey AT. Postoperative spinal epidural hematoma (SEH): incidence, risk factors, onset, and management. Spine J. 2013 Feb;13(2):134-40. doi: 10.1016/j.spinee.2012.10.028. Epub 2012 Dec 5. — View Citation

Delamarter RB, Sherman J, Carr JB. Pathophysiology of spinal cord injury. Recovery after immediate and delayed decompression. J Bone Joint Surg Am. 1995 Jul;77(7):1042-9. — View Citation

Fujita N, Michikawa T, Yagi M, Suzuki S, Tsuji O, Nagoshi N, Okada E, Tsuji T, Nakamura M, Matsumoto M, Watanabe K. Impact of lumbar hypolordosis on the incidence of symptomatic postoperative spinal epidural hematoma after decompression surgery for lumbar — View Citation

Fujiwara Y, Manabe H, Izumi B, Harada T, Nakanishi K, Tanaka N, Adachi N. The impact of hypertension on the occurrence of postoperative spinal epidural hematoma following single level microscopic posterior lumbar decompression surgery in a single institut — View Citation

Hohenberger C, Zeman F, Höhne J, Ullrich OW, Brawanski A, Schebesch KM. Symptomatic Postoperative Spinal Epidural Hematoma after Spinal Decompression Surgery: Prevalence, Risk Factors, and Functional Outcome. J Neurol Surg A Cent Eur Neurosurg. 2020 Jul;8 — View Citation

Kao FC, Tsai TT, Chen LH, Lai PL, Fu TS, Niu CC, Ho NY, Chen WJ, Chang CJ. Symptomatic epidural hematoma after lumbar decompression surgery. Eur Spine J. 2015 Feb;24(2):348-57. doi: 10.1007/s00586-014-3297-8. Epub 2014 Apr 24. — View Citation

Knusel K, Du JY, Ren B, Kim CY, Ahn UM, Ahn NU. Symptomatic Epidural Hematoma after Elective Posterior Lumbar Decompression: Incidence, Timing, Risk Factors, and Associated Complications. HSS J. 2020 Dec;16(Suppl 2):230-237. doi: 10.1007/s11420-019-09690- — View Citation

Leonardi MA, Zanetti M, Saupe N, Min K. Early postoperative MRI in detecting hematoma and dural compression after lumbar spinal decompression: prospective study of asymptomatic patients in comparison to patients requiring surgical revision. Eur Spine J. 2 — View Citation

Mueller K, Altshuler M, Voyadzis JM, Sandhu FA. The incidence of symptomatic postoperative epidural hematoma after minimally invasive lumbar decompression: A single institution retrospective review. Clin Neurol Neurosurg. 2020 Aug;195:105868. doi: 10.1016 — View Citation

Yamada K, Abe Y, Satoh S, Yanagibashi Y, Hyakumachi T, Masuda T. Large Increase in Blood Pressure After Extubation and High Body Mass Index Elevate the Risk of Spinal Epidural Hematoma After Spinal Surgery. Spine (Phila Pa 1976). 2015 Jul 1;40(13):1046-52 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large local kyphosis angle	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	6 months
Primary	High occupying ratio of cross-sectional area	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.	6 months
Primary	Cerebrospinal fluid leakage	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	6 months