Spinal Cord InjuriesNCT03103516
Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function
A study testing early epidural decompression group and delayed epidural decompression group in people with Spinal Cord Injuries, run by Peking University People's Hospital at 4 sites in China.
Trial summary
To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- early epidural decompression group and delayed epidural decompression group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2017to Dec 2020
- Phase
- Interventional
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000);
- Final diagnosis by spine CT and/or MRI;
- Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury;
- No other injury involving life, injury severity score < 16;
- No anesthesia contraindication;
- No local skin infection, no severe soft tissue contusion, soft tissue condition of the operation area met the operation requirements;
- Age: 16-85 years old, irrespective of sex.
Who cannot join
- Active or recent severe infection
- Severe infectious diseases that need to be treated in infectious disease hospital;
- History of mental illness;
- History of metal allergy;
- Long-term alcohol abuse and drug abuse;
- Do not agree to participate in this trial; the legal representative of the patient refuses to sign informed consent;
- Poor compliance, cannot be followed up as required.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100020
Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences
Beijing, Beijing Municipality, 100050
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Fang Zhou, M.D., 8613801153767, zhou.md@126.com
Fang Zhou, M.D.
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Tiansheng Sun, M.D., 8613501072165, suntiansheng-@163.com
Tiansheng Sun, M.D.
About this study
Official title: Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function: a Prospective, Multicenter, Non-randomized, Controlled Trial
To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months.
Read the detailed description
Whether early epidural decompression surgery can restore neurological function in patients with acute spinal cord injury (complete and incomplete), and an effective time window for epidural decompression, are still controversial.
This trial will verify whether early epidural decompression surgery is more conducive to the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) compared with delayed surgery. This trial will begin in August 2017. Data analysis of 200 patients will be finished in December 2019. All results will be completed in December 2020. This trial will provide clinical evidences for the selection of timing of epidural decompression surgery in patients with complete and incomplete spinal cord injury.
Adverse events Adverse events will be obtained from patients or their legal representatives. Major adverse events will include: limb paralysis deterioration, re-operation, respirator use (more than 1 week), tracheostomy, septicemia, pneumonia, acute respiratory distress syndrome, atelectasis, other respiratory complications, wound infection (superficial and deep), urinary tract infection, other infections, gastrointestinal bleeding, peptic ulcer, intestinal obstruction, acute myocardial infarction, other heart events, pulmonary embolism, cerebrovascular complication, hepatic failure, renal failure, delirium and depression.
Statistical methods
- All data will be analyzed using SPSS 19.0 software.
- Normally distributed measurement data will be expressed as mean, SD, minimums, and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data will be presented as the percentage.
- Measurement data among groups will be compared using two-sample t-test or Mann-Whitney U test.
- Count data will be analyzed using chi square test or Fisher's exact test. Ranked data will be analyzed using Wilcoxon signed-rank test.
Sample size ASIA motor score is one of the main outcome measures. In accordance with a previous study (Chikuda et al., 2013), taking power = 0.8 with a significance level of α = 0.05, we will need 45 patients per group when the difference to be detected in the ASIA motor score between the groups is 12 points and the common standard deviation is 20. If we assume a patient loss rate of 20%, we will require 54 patients per group, totally 108 patients. We therefore aim to include 200 patients in accordance with previous conditions on acute spinal cord injury (complete and incomplete) treatment in participating units.
Data management
- All data will be input into the spinal cord injury treatment database. After the completion of the study, the research group and third-party statistical staffs will carry out data collation and analysis.
- The participating units are responsible for filling in the information database. Data consistency and logic will be checked by computer program combined with manual review. Any questions will be answered by the person in charge of the project and the main staff, and returned to the data management center, and then the data manager will modify and update the database.
- All inspection procedures need to be repeated several times until there is no doubt. All changes and updates are required for recording and filing. It is strictly forbidden to use correction fluid or correction tape. All researchers are required to ensure that the data recorded in the case report forms are authentic.
- Conditions
- Spinal Cord Injuries
- Being tested
- early epidural decompression group, delayed epidural decompression group
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early epidural decompression groupProcedure or surgery
The patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.
delayed epidural decompression groupProcedure or surgery
The patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.
| Study group | Role | What they receive |
|---|---|---|
| early epidural decompression group | Experimental | The patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. Receives: Procedure: early epidural decompression group |
| delayed epidural decompression group | Experimental | The patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. Receives: Procedure: delayed epidural decompression group |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) motor and sensory scores
To assess spinal nerve function. Evaluation criteria for neurological function after spinal cord injury: Neurological function will be evaluated in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000).
Measured: at postoperative 6 months
Secondary outcomes (2)
American Spinal Injury Association (ASIA) impairment scale
to assess spinal nerve function
Measured: changes of week 1, month 1 and month 3 after surgery
Evaluation of the incidence of complications
to assess the incidence of complications.The percentage of the number of cases of postoperative complications to total cases will be calculated.
Measured: changes of week 1, month 1, month 3 and month 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startAug 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 200 acute spinal cord injury patients (complete and incomplete) will undergo pre-hospital treatment in the Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center, and will receive in-hospital treatment in the Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. There were 100 patients undergoing epidural decompression surgery within 24 hours and 100 patients receiving surgery after 24 hours.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoguo Jiang, Peking University People's Hospital
- Investigators
- Baoguo Jiang, Ph.D, Principal investigator, Department of Orthopedics, Peking University People's Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103516
- Sponsor's protocol ID
- PekingUPH_003
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sizheng Z, Boxuan H, Feng X, Dianying Z. A functional outcome prediction model of acute traumatic spinal cord injury based on extreme gradient boost. J Orthop Surg Res. 2022 Oct 12;17(1):451. doi: 10.1186/s13018-022-03343-7.
PubMed 36224595
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function: a Prospective, Multicenter, Non-randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03103516
- Acronym / sponsor ID
- PekingUPH_003
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Apr 2017 (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.
To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months.
Detailed description
Whether early epidural decompression surgery can restore neurological function in patients with acute spinal cord injury (complete and incomplete), and an effective time window for epidural decompression, are still controversial.
This trial will verify whether early epidural decompression surgery is more conducive to the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) compared with delayed surgery. This trial will begin in August 2017. Data analysis of 200 patients will be finished in December 2019. All results will be completed in December 2020. This trial will provide clinical evidences for the selection of timing of epidural decompression surgery in patients with complete and incomplete spinal cord injury.
Adverse events Adverse events will be obtained from patients or their legal representatives. Major adverse events will include: limb paralysis deterioration, re-operation, respirator use (more than 1 week), tracheostomy, septicemia, pneumonia, acute respiratory distress syndrome, atelectasis, other respiratory complications, wound infection (superficial and deep), urinary tract infection, other infections, gastrointestinal bleeding, peptic ulcer, intestinal obstruction, acute myocardial infarction, other heart events, pulmonary embolism, cerebrovascular complication, hepatic failure, renal failure, delirium and depression.
Statistical methods
- All data will be analyzed using SPSS 19.0 software.
- Normally distributed measurement data will be expressed as mean, SD, minimums, and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data will be presented as the percentage.
- Measurement data among groups will be compared using two-sample t-test or Mann-Whitney U test.
- Count data will be analyzed using chi square test or Fisher's exact test. Ranked data will be analyzed using Wilcoxon signed-rank test.
Sample size ASIA motor score is one of the main outcome measures. In accordance with a previous study (Chikuda et al., 2013), taking power = 0.8 with a significance level of α = 0.05, we will need 45 patients per group when the difference to be detected in the ASIA motor score between the groups is 12 points and the common standard deviation is 20. If we assume a patient loss rate of 20%, we will require 54 patients per group, totally 108 patients. We therefore aim to include 200 patients in accordance with previous conditions on acute spinal cord injury (complete and incomplete) treatment in participating units.
Data management
- All data will be input into the spinal cord injury treatment database. After the completion of the study, the research group and third-party statistical staffs will carry out data collation and analysis.
- The participating units are responsible for filling in the information database. Data consistency and logic will be checked by computer program combined with manual review. Any questions will be answered by the person in charge of the project and the main staff, and returned to the data management center, and then the data manager will modify and update the database.
- All inspection procedures need to be repeated several times until there is no doubt. All changes and updates are required for recording and filing. It is strictly forbidden to use correction fluid or correction tape. All researchers are required to ensure that the data recorded in the case report forms are authentic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 200 acute spinal cord injury patients (complete and incomplete) will undergo pre-hospital treatment in the Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center, and will receive in-hospital treatment in the Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. There were 100 patients undergoing epidural decompression surgery within 24 hours and 100 patients receiving surgery after 24 hours.
| Arm | Type | Receives |
|---|---|---|
| early epidural decompression group | Experimental | Procedure: early epidural decompression groupThe patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. |
| delayed epidural decompression group | Experimental | Procedure: delayed epidural decompression groupThe patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000);
- Final diagnosis by spine CT and/or MRI;
- Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury;
- No other injury involving life, injury severity score < 16;
- No anesthesia contraindication;
Key exclusion criteria (7 listed)
- Active or recent severe infection
- Severe infectious diseases that need to be treated in infectious disease hospital;
- History of mental illness;
- History of metal allergy;
- Long-term alcohol abuse and drug abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early epidural decompression groupThe patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. | Procedure or surgery | early epidural decompression group |
| delayed epidural decompression groupThe patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time. | Procedure or surgery | delayed epidural decompression group |
Primary outcome
American Spinal Injury Association (ASIA) motor and sensory scores
Time frame: at postoperative 6 months
To assess spinal nerve function. Evaluation criteria for neurological function after spinal cord injury: Neurological function will be evaluated in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000).
2 secondary outcomes
American Spinal Injury Association (ASIA) impairment scale
Time frame: changes of week 1, month 1 and month 3 after surgery
Evaluation of the incidence of complications
Time frame: changes of week 1, month 1, month 3 and month 6 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Derived from this study: PubMed 36224595Sizheng Z, Boxuan H, Feng X, Dianying Z. A functional outcome prediction model of acute traumatic spinal cord injury based on extreme gradient boost. J Orthop Surg Res. 2022 Oct 12;17(1):451. doi: 10.1186/s13018-022-03343-7.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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.
Baoguo Jiang, Ph.D principal investigator
Department of Orthopedics, Peking University People's Hospital, Beijing, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early epidural decompression group and delayed epidural decompression group in people with Spinal Cord Injuries, run by Peking University People's Hospital at 4 sites 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Xue, Ph.D (8618811331636, 317108233@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association (ASIA) motor and sensory scores (time frame: at postoperative 6 months). 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 NCT03103516, which also lists 1 linked publication.
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 17 Apr 2017.