Traumatic Brain InjuryNCT03222297
Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery
An observational study of Traumatic Brain Injury, run by Taihe Hospital.
Trial summary
To evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh. To determine the best timing for skull repair using the three-dimensional titanium mesh; to compare the effects of early (1-3 months after… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- early skull repair and late-stage skull repair
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to Dec 2017
- 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 20 to 65 years
- All sexes
- Adult, Older adult
Study population: Eighty-six patients with craniocerebral injury who had undergone decompression with removal of bone flap from January 2013 to January 2016 were recruited and subjected to skull repair using titanium mesh. All the patients were randomized into two groups: test group (n = 40) with early skull repair within 1-3 months after decompression and control group (n = 46) with late-stage skull repair within 6-12 months after decompression.
Who may be able to join
- Patients underwent decompression via removal of bone flap in the unilateral frontal temporal lobe due to craniocerebral injury and developed no postoperative infection.
- Patients agreed to receive skull repair using titanium mesh.
- Patients and their families agreed to receive CT perfusion examination.
- Patients and their families fully understood the study protocol and agreed to participate in the trial, and then singed the informed consent before the trial.
Who cannot join
- Hypertension and diabetes out of control, severe heart disease, brain tumors, brain abscess, and cerebral infarction
- Diseases that have interfered with localized perfusion data, such as intracranial aneurysms, arteriovenous malformations
- Combined with depressed skull fractures and skull base fractures
- Hydrocephalus
About this study
Official title: Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery: a Randomized Controlled Clinical Trial Based on CT Perfusion Evaluation
To evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh. To determine the best timing for skull repair using the three-dimensional titanium mesh; to compare the effects of early (1-3 months after decompression) and late-stage (6-12 months after decompression) skull repair on neurologic rehabilitation.
Read the detailed description
A skull defect is inevitable in patients with traumatic brain injury undergoing decompression treatment, which results in a loss of physiological and functional integrity of the brain that makes atmospheric pressure directly act on the brain tissue to induce environmental disorders in the brain. Moreover, with the changes in the body position, the contents of the brain often move in an unstable position, and with the extension of time, there may be compensatory ventricular enlargement and brain atrophy, eventually causing neurological dysfunction and cognitive disorders. Therefore, it is imperative to repair the skull defect.
There are many repair materials for skull defects, including autogenous bone, allogeneic bone, nonmetallic materials (plexiglass, bone cement, silicone rubber, etc.) and titanium mesh. The performance of different materials have their own advantages and disadvantages, and titanium alloy is an ideal repair material and has been widely used in clinical practice because of good biocompatibility and strength, no aging, low density, non-iron atoms, ability to be not magnetized in magnetic fields, and no influence on CT, MRI, EEG and X-ray examination.
The timing for repair of skull defect after traumatic brain injury is still controversial. Some scholars believe that if there is no hydrocephalus and intracranial infection after decompression with removal of bone flap, skull repair should be proceeded as soon as possible to isolate the scalp from the dura mater and recover the normal intracranial pressure by easing the negative effects of the scalp, such as cerebrovascular traction, compression and distortions. Most importantly, early skull repair is able to reduce a variety of secondary neurological deficits due to skull defects, increase brain surface blood flow, and thus reduce epileptic attack. Of course, some scholars recommend late-stage skull repair, and they believe hematoma absorption after decompressive surgery is a long process, and in some patients, hematoma will be completely absorbed in about 3 months or even longer, which may result in secondary brain edema. Moreover, surgical trauma exerts negative effect on the brain tissue recovery, which is not conducive to neurologic rehabilitation.
As there is no unified conclusion on the timing for the repair of skull defects, investigators conducted a multi-sample, double-blind, randomized, clinical trial, to collect craniocerebral injury patients undergoing decompression with removal of bone graft who were randomized into two groups to receive early skull repair in test group and late-stage skull repair in control group. CT perfusion technology was used to monitor the blood perfusion in the brain before and after skull repair and to compare the changes of blood perfusion in the brain tissue and neurological recovery in patients undergoing early or late-stage skull repair.
- Conditions
- Traumatic Brain Injury
- Being tested
- early skull repair, late-stage skull repair
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early skull repairDevice
Also called test group
Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.
late-stage skull repairDevice
Also called control group
Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.
| Study group | Role | What they receive |
|---|---|---|
| test group | Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression. Receives: Device: early skull repair | |
| control group | Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression. Receives: Device: late-stage skull repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood perfusion in the brain tissue
To monitor the changes of blood perfusion in the brain tissue based on CT perfusion technology after skull repair with titanium mesh. 50 mL of iopromide was injected at a rate of 5 mL/s into the median cubital vein of the patients, and 3 seconds later, 256-slice spiral CT (Philips) was used for continuous scan for 50 seconds, followed by image processing using a Philips-specific workstation.
Measured: changes from day 3 before surgery to day 10 after surgery
Secondary outcomes (1)
Barthel index
To measure performance in activities of daily living. The full scores of Barthel index is 100. A higher score is associated with a greater likelihood of being able to live: > 60, mild disability with the ability to basically take care of oneself; 40-60, moderate disability with the need for help in activities of daily living; 20-40, severe disability with the need for great help in activities of daily living; < 20, complete disability with the inability to care for oneself.
Measured: at day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jan 2013
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taihe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yase Zhuang, Taihe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222297
- Sponsor's protocol ID
- TaiheH_002
- Status last verified
- Feb 2018
- First submitted
- 12 Jul 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery: a Randomized Controlled Clinical Trial Based on CT Perfusion Evaluation
- ClinicalTrials.gov ID
- NCT03222297
- Acronym / sponsor ID
- TaiheH_002
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Taihe HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jul 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 evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh. To determine the best timing for skull repair using the three-dimensional titanium mesh; to compare the effects of early (1-3 months after decompression) and late-stage (6-12 months after decompression) skull repair on neurologic rehabilitation.
Detailed description
A skull defect is inevitable in patients with traumatic brain injury undergoing decompression treatment, which results in a loss of physiological and functional integrity of the brain that makes atmospheric pressure directly act on the brain tissue to induce environmental disorders in the brain. Moreover, with the changes in the body position, the contents of the brain often move in an unstable position, and with the extension of time, there may be compensatory ventricular enlargement and brain atrophy, eventually causing neurological dysfunction and cognitive disorders. Therefore, it is imperative to repair the skull defect.
There are many repair materials for skull defects, including autogenous bone, allogeneic bone, nonmetallic materials (plexiglass, bone cement, silicone rubber, etc.) and titanium mesh. The performance of different materials have their own advantages and disadvantages, and titanium alloy is an ideal repair material and has been widely used in clinical practice because of good biocompatibility and strength, no aging, low density, non-iron atoms, ability to be not magnetized in magnetic fields, and no influence on CT, MRI, EEG and X-ray examination.
The timing for repair of skull defect after traumatic brain injury is still controversial. Some scholars believe that if there is no hydrocephalus and intracranial infection after decompression with removal of bone flap, skull repair should be proceeded as soon as possible to isolate the scalp from the dura mater and recover the normal intracranial pressure by easing the negative effects of the scalp, such as cerebrovascular traction, compression and distortions. Most importantly, early skull repair is able to reduce a variety of secondary neurological deficits due to skull defects, increase brain surface blood flow, and thus reduce epileptic attack. Of course, some scholars recommend late-stage skull repair, and they believe hematoma absorption after decompressive surgery is a long process, and in some patients, hematoma will be completely absorbed in about 3 months or even longer, which may result in secondary brain edema. Moreover, surgical trauma exerts negative effect on the brain tissue recovery, which is not conducive to neurologic rehabilitation.
As there is no unified conclusion on the timing for the repair of skull defects, investigators conducted a multi-sample, double-blind, randomized, clinical trial, to collect craniocerebral injury patients undergoing decompression with removal of bone graft who were randomized into two groups to receive early skull repair in test group and late-stage skull repair in control group. CT perfusion technology was used to monitor the blood perfusion in the brain before and after skull repair and to compare the changes of blood perfusion in the brain tissue and neurological recovery in patients undergoing early or late-stage skull repair.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | Device: early skull repairPatients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression. |
| control group | – | Device: late-stage skull repairPatients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eighty-six patients with craniocerebral injury who had undergone decompression with removal of bone flap from January 2013 to January 2016 were recruited and subjected to skull repair using titanium mesh. All the patients were randomized into two groups: test group (n = 40) with early skull repair within 1-3 months after decompression and control group (n = 46) with late-stage skull repair within 6-12 months after decompression.
Key inclusion criteria (4 listed)
- Patients underwent decompression via removal of bone flap in the unilateral frontal temporal lobe due to craniocerebral injury and developed no postoperative infection.
- Patients agreed to receive skull repair using titanium mesh.
- Patients and their families agreed to receive CT perfusion examination.
- Patients and their families fully understood the study protocol and agreed to participate in the trial, and then singed the informed consent before the trial.
Key exclusion criteria (4 listed)
- Hypertension and diabetes out of control, severe heart disease, brain tumors, brain abscess, and cerebral infarction
- Diseases that have interfered with localized perfusion data, such as intracranial aneurysms, arteriovenous malformations
- Combined with depressed skull fractures and skull base fractures
- Hydrocephalus
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 skull repairAlso: test groupPatients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression. | Device | test group |
| late-stage skull repairAlso: control groupPatients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression. | Device | control group |
Primary outcome
blood perfusion in the brain tissue
Time frame: changes from day 3 before surgery to day 10 after surgery
To monitor the changes of blood perfusion in the brain tissue based on CT perfusion technology after skull repair with titanium mesh. 50 mL of iopromide was injected at a rate of 5 mL/s into the median cubital vein of the patients, and 3 seconds later, 256-slice spiral CT (Philips) was used for continuous scan for 50 seconds, followed by image processing using a Philips-specific workstation.
1 secondary outcome
Barthel index
Time frame: at day 30 after surgery
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 9 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Taihe Hospital.
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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
blood perfusion in the brain tissue (time frame: changes from day 3 before surgery to day 10 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2018.