Spinal Epidural HematomaNCT04961424
Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute
An observational study of Spinal Epidural Hematoma and Thoracic Surgery, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Epidural Hematoma, Thoracic Surgery
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2020to 18 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between January 2010 and December 2019, 1612 patients were performed thoracic decompression surgery due to thoracic spinal stenosis (TSS) caused by thoracic disc herniation, ossification of posterior longitudinal ligament and ligamentum flavum with/without posterior instrumentation in our institution. The SSEH group patients were determined by symptom, MRI, intraoperative finding and underwent hematoma evacuation within one weeks of the initial surgery. For the control group, those who did not develop the SSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the detailed 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.
- Conditions
- Spinal Epidural Hematoma, Thoracic Surgery
- Keywords
- symptomatic spinal epidural hematoma, posterior thoracic surgery, local kyphosis angle, occupying ratio of cross-sectional area, cerebrospinal fluid leakage.
- Medical subject headings
- Hematoma, Epidural, Spinal, Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic spinal epidural hematoma Group | Patients who performed thoracic decompression surgery and developed neurological deficit after surgery due to the symptomatic spinal epidural hematoma were enrolled into case group. | |
| Control group | hose who did not develop the symptomatic spinal epidural hematoma, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start19 Feb 2020
- Primary completion19 Feb 2020
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal Epidural HematomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Weishi, Peking University Third Hospital
- Investigators
- Weishi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961424
- Sponsor's protocol ID
- M2020006
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make the clinical study report available for half a year after the publication of the results of the studys
Publications
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. 2010 Dec;19(12):2216-22. doi: 10.1007/s00586-010-1483-x. Epub 2010 Jun 17.
PubMed 20556438Amiri 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.
PubMed 23218510Delamarter 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. doi: 10.2106/00004623-199507000-00010.
PubMed 7608226Yamada 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. doi: 10.1097/BRS.0000000000000876.
PubMed 25768686Fujiwara 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 institute. Eur Spine J. 2017 Oct;26(10):2606-2615. doi: 10.1007/s00586-017-5165-9. Epub 2017 Jun 9.
PubMed 28597302Kao 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.
PubMed 24760464Fujita 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 spinal canal stenosis. Eur Spine J. 2019 Jan;28(1):87-93. doi: 10.1007/s00586-018-5782-y. Epub 2018 Oct 9.
PubMed 30302540Knusel 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/s11420-019-09690-2. Epub 2019 Jul 1.
PubMed 33380952Hohenberger C, Zeman F, Hohne 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;81(4):290-296. doi: 10.1055/s-0039-1697024. Epub 2020 Jan 14.
PubMed 31935784Mueller 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/j.clineuro.2020.105868. Epub 2020 Apr 22.
PubMed 32361024
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute
- ClinicalTrials.gov ID
- NCT04961424
- Acronym / sponsor ID
- M2020006
- Conditions
- Spinal Epidural Hematoma, Thoracic Surgery
- Keywords
- symptomatic spinal epidural hematoma, posterior thoracic surgery, local kyphosis angle, occupying ratio of cross-sectional area, cerebrospinal fluid leakage.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic spinal epidural hematoma Group | – | –Patients who performed thoracic decompression surgery and developed neurological deficit after surgery due to the symptomatic spinal epidural hematoma were enrolled into case group. |
| Control group | – | –hose who did not develop the symptomatic spinal epidural hematoma, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between January 2010 and December 2019, 1612 patients were performed thoracic decompression surgery due to thoracic spinal stenosis (TSS) caused by thoracic disc herniation, ossification of posterior longitudinal ligament and ligamentum flavum with/without posterior instrumentation in our institution. The SSEH group patients were determined by symptom, MRI, intraoperative finding and underwent hematoma evacuation within one weeks of the initial surgery. For the control group, those who did not develop the SSEH, underwent the same procedures of similar complexity at the same section of thoracic spine in the same period (the same year or the following year) were randomly selected from the pool of patients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Results publication: PubMed 20556438Leonardi 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. 2010 Dec;19(12):2216-22. doi: 10.1007/s00586-010-1483-x. Epub 2010 Jun 17.
- Results publication: PubMed 23218510Amiri 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.
- Results publication: PubMed 7608226Delamarter 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. doi: 10.2106/00004623-199507000-00010.
- Results publication: PubMed 25768686Yamada 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. doi: 10.1097/BRS.0000000000000876.
- Results publication: PubMed 28597302Fujiwara 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 institute. Eur Spine J. 2017 Oct;26(10):2606-2615. doi: 10.1007/s00586-017-5165-9. Epub 2017 Jun 9.
- Results publication: PubMed 24760464Kao 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.
- Results publication: PubMed 30302540Fujita 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 spinal canal stenosis. Eur Spine J. 2019 Jan;28(1):87-93. doi: 10.1007/s00586-018-5782-y. Epub 2018 Oct 9.
- Results publication: PubMed 33380952Knusel 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/s11420-019-09690-2. Epub 2019 Jul 1.
- Results publication: PubMed 31935784Hohenberger C, Zeman F, Hohne 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;81(4):290-296. doi: 10.1055/s-0039-1697024. Epub 2020 Jan 14.
- Results publication: PubMed 32361024Mueller 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/j.clineuro.2020.105868. Epub 2020 Apr 22.
- Individual participant dataSharing planned: Yes. We will make the clinical study report available for half a year after the publication of the results of the studys
Related trials for Spinal Epidural Hematoma
RecruitingObservational study
Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma
Spinal Epidural Hematoma
Not yet recruitingObservational study
Outcomes of Traumatic Intracranial Hemorrhage in the Elderly
Traumatic Brain Injury, Subdural Hematoma
RecruitingObservational study
Neurosurgical Outcome Network
Aneurysms, Arteriovenous Malformations
RecruitingObservational study
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
Epidural Hematoma, Decompressive Craniectomy
Active, not recruiting
Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma
Epidural Hematoma, Brain Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weishi Li, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Epidural Hematoma and Thoracic Surgery, 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 4 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: finished, as of the sponsor's last update on 14 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large local kyphosis angle (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04961424, which also lists 10 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 14 Jul 2021.