Craniocerebral TraumaTIMELYNCT06632587
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
A study testing Early cranioplasty and Standard-of-care cranioplasty in people with Craniocerebral Trauma and Stroke, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Craniocerebral Trauma, Stroke, Intracranial Hemorrhages
- What is being tested?
- Early cranioplasty and Standard-of-care cranioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC)
- Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689)
- Medically optimized for general anesthesia/surgery
Who cannot join
- Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia)
- Cranial infection in the post-DHC period
- Patient deemed not appropriate for early cranioplasty by attending neurosurgeon
- Patient mortality prior to 8 weeks post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure causing brain injury secondary to stroke or intracranial hemorrhage")
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
Pious Patel, MD, (215) 955-7000
About this study
Official title: Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).
Read the detailed description
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).
The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage"). This assessment aims to determine whether the timing of cranioplasty influences patients' neurological recovery, cognitive function, and overall quality of life. By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty, the study seeks to provide valuable insights into the potential benefits of the latter approach.
The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC. By considering a range of complications and incorporating a robust statistical framework, the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies.
- Conditions
- Craniocerebral Trauma, Stroke, Intracranial Hemorrhages
- Being tested
- Early cranioplasty, Standard-of-care cranioplasty
- Keywords
- Decompressive hemicraniectomy, cranioplasty, cranial trauma, stroke, intracranial hemorrhage, intracerebral hemorrhage, neurosurgery
- Medical subject headings
- Craniocerebral Trauma, Stroke, Intracranial Hemorrhages, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cranioplastyProcedure or surgery
Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.
Standard-of-care cranioplastyProcedure or surgery
Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.
| Study group | Role | What they receive |
|---|---|---|
| Early cranioplasty | Active comparator | Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy. Receives: Procedure: Early cranioplasty |
| Standard-of-care cranioplasty | Placebo comparator | Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy. Receives: Procedure: Standard-of-care cranioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome at 6 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy
Measured: 6 months post-decompressive hemicraniectomy
Functional outcome at 12 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy
Measured: 12 months post-decompressive hemicraniectomy
Secondary outcomes (7)
Post-cranioplasty seizure
Post-cranioplasty seizure occurrence, diagnosed clinically or on EEG
Measured: 1 month post-cranioplasty
Post-cranioplasty hydrocephalus
Post-cranioplasty hydrocephalus or need for cerebrospinal fluid diversion
Measured: 1 month post-cranioplasty
Post-cranioplasty return to operating room
All-cause return to operating room after cranioplasty
Measured: 1 month post-cranioplasty
Post-cranioplasty infection
Surgical site or intracranial infection after cranioplasty
Measured: 12 months post-cranioplasty
Post-cranioplasty disposition
Post-cranioplasty disposition (home, acute rehab, subacute rehab, death)
Measured: 12 months post-cranioplasty
Post-cranioplasty length of hospital stay
Post-cranioplasty length of hospital stay
Measured: 12 months post-cranioplasty
Readmission within 30 days post-cranioplasty
Readmission within 30 days post-cranioplasty
Measured: 30 days post-cranioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pious Patel, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632587
- Sponsor's protocol ID
- iRISID-2024-3103
- Acronym
- TIMELY
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel PD, Khanna O, Gooch MR, Glener SR, Mouchtouris N, Momin AA, Sioutas G, Amllay A, Barsouk A, El Naamani K, Yudkoff C, Wyler DA, Jallo JI, Tjoumakaris S, Jabbour PM, Harrop JS. Clinical Outcomes After Ultra-Early Cranioplasty Using Craniectomy Contour Classification as a Patient Selection Criterion. Oper Neurosurg. 2023 Jul 1;25(1):72-80. doi: 10.1227/ons.0000000000000689. Epub 2023 May 5.
PubMed 37166197Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182.
PubMed 28419358Eaton JC, Greil ME, Nistal D, Caldwell DJ, Robinson E, Aljuboori Z, Temkin N, Bonow RH, Chesnut RM. Complications associated with early cranioplasty for patients with traumatic brain injury: a 25-year single-center analysis. J Neurosurg. 2022 Jan 21;137(3):776-781. doi: 10.3171/2021.11.JNS211557. Print 2022 Sep 1.
PubMed 35061995Sethi A, Chee K, Kaakani A, Beauchamp K, Kang J. Ultra-Early Cranioplasty versus Conventional Cranioplasty: A Retrospective Cohort Study at an Academic Level 1 Trauma Center. Neurotrauma Rep. 2022 Aug 1;3(1):286-291. doi: 10.1089/neur.2022.0026. eCollection 2022.
PubMed 36060455
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
- ClinicalTrials.gov ID
- NCT06632587
- Acronym / sponsor ID
- TIMELY / iRISID-2024-3103
- Conditions
- Craniocerebral Trauma, Stroke, Intracranial Hemorrhages
- Keywords
- Decompressive hemicraniectomy, cranioplasty, cranial trauma, stroke, intracranial hemorrhage, intracerebral hemorrhage, neurosurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Oct 2024 (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 prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).
Detailed description
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).
The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage"). This assessment aims to determine whether the timing of cranioplasty influences patients' neurological recovery, cognitive function, and overall quality of life. By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty, the study seeks to provide valuable insights into the potential benefits of the latter approach.
The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC. By considering a range of complications and incorporating a robust statistical framework, the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cranioplasty | Active comparator | Procedure: Early cranioplastyCranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy. |
| Standard-of-care cranioplasty | Placebo comparator | Procedure: Standard-of-care cranioplastyCranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC)
- Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689)
- Medically optimized for general anesthesia/surgery
Key exclusion criteria (4 listed)
- Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia)
- Cranial infection in the post-DHC period
- Patient deemed not appropriate for early cranioplasty by attending neurosurgeon
- Patient mortality prior to 8 weeks post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure causing brain injury secondary to stroke or intracranial hemorrhage")
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 cranioplastyCranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy. | Procedure or surgery | Early cranioplasty |
| Standard-of-care cranioplastyCranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy. | Procedure or surgery | Standard-of-care cranioplasty |
Primary outcome
Functional outcome at 6 months post-decompressive hemicraniectomy
Time frame: 6 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 6 months post-decompressive hemicraniectomy
Functional outcome at 12 months post-decompressive hemicraniectomy
Time frame: 12 months post-decompressive hemicraniectomy
modified Rankin scale outcome at 12 months post-decompressive hemicraniectomy
7 secondary outcomes
Post-cranioplasty seizure
Time frame: 1 month post-cranioplasty
Post-cranioplasty hydrocephalus
Time frame: 1 month post-cranioplasty
Post-cranioplasty return to operating room
Time frame: 1 month post-cranioplasty
Post-cranioplasty infection
Time frame: 12 months post-cranioplasty
Post-cranioplasty disposition
Time frame: 12 months post-cranioplasty
Post-cranioplasty length of hospital stay
Time frame: 12 months post-cranioplasty
Readmission within 30 days post-cranioplasty
Time frame: 30 days post-cranioplasty
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 37166197Patel PD, Khanna O, Gooch MR, Glener SR, Mouchtouris N, Momin AA, Sioutas G, Amllay A, Barsouk A, El Naamani K, Yudkoff C, Wyler DA, Jallo JI, Tjoumakaris S, Jabbour PM, Harrop JS. Clinical Outcomes After Ultra-Early Cranioplasty Using Craniectomy Contour Classification as a Patient Selection Criterion. Oper Neurosurg. 2023 Jul 1;25(1):72-80. doi: 10.1227/ons.0000000000000689. Epub 2023 May 5.
- Background: PubMed 28419358Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182.
- Background: PubMed 35061995Eaton JC, Greil ME, Nistal D, Caldwell DJ, Robinson E, Aljuboori Z, Temkin N, Bonow RH, Chesnut RM. Complications associated with early cranioplasty for patients with traumatic brain injury: a 25-year single-center analysis. J Neurosurg. 2022 Jan 21;137(3):776-781. doi: 10.3171/2021.11.JNS211557. Print 2022 Sep 1.
- Background: PubMed 36060455Sethi A, Chee K, Kaakani A, Beauchamp K, Kang J. Ultra-Early Cranioplasty versus Conventional Cranioplasty: A Retrospective Cohort Study at an Academic Level 1 Trauma Center. Neurotrauma Rep. 2022 Aug 1;3(1):286-291. doi: 10.1089/neur.2022.0026. eCollection 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early cranioplasty and Standard-of-care cranioplasty in people with Craniocerebral Trauma and Stroke, run by Thomas Jefferson University at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pious Patel, MD ((215) 955-7000, pious.patel@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome at 6 months post-decompressive hemicraniectomy (time frame: 6 months post-decompressive hemicraniectomy). The study lists 2 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 NCT06632587, which also lists 4 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 23 Jul 2025.