Traumatic Brain InjuryNCT03653728
Near Infra-red Spectroscopy for Detection of Intracranial Haematoma
An observational study of Traumatic Brain Injury and Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Intracerebral Hemorrhage
- What is being tested?
- Near infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2022to 31 Mar 2023
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive traumatic brain injury patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS).
Who may be able to join
- Age greater than or equal to 18 years old,
- History of traumatic brain injury,
- Radiological evidence of intracranial haematoma,
- Glasgow Coma Scale (GCS) less than 15 upon admission,
- Not undergoing immediate operation,
- Admission to the general ward or high dependence unit of Neurosurgery, Prince of Wales Hospital.
Who cannot join
- Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,
- Presence of pneumocephale,
- Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.
- Patients who have joined other drug trial in the last four weeks;
- Pregnant or on breast feeding;
- Any other reasons that the researchers consider unsuitable.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, Hong Kong
Hong Kong, 852
About this study
Official title: Non-invasive Neuro-monitoring for Head Injury: Use of Near Infra-red Spectroscopy for Early Detection of Delayed Intracranial Haematoma
Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.
Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these noninvasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources. Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as nearinfrared spectroscopy (NIRS) is to be investigated.
The aim of this study is to determine the sensitivity and specificity of NIRS as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain. Study design is Prospective sensitivity and specificity study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited. Outcome measures including correlation of non-invasive monitoring with near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect. Secondary outcome including 30 days mortality and functional outcome at 3 months.
Read the detailed description
Introduction: Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.
Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these non-invasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources.
Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as near-infrared spectroscopy (NIRS) is to be investigated.
Aims and Hypotheses to be tested:
The aim of this study is to determine the sensitivity and specificity of near-infrared spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain.
Plan of Investigation:
This is a prospective sensitivity and specificity correlation study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited.
Consecutive patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS). Criteria to proceed for repeat CT Brain scan 1) clinical deterioration of GCS >2 points, 2) NIRS monitoring has increase in difference in absorbance of light at 760nm >0.3, or 3) 8 hours after admission for baseline interval scan for all patients as part of the standard of care. Non-invasive monitoring with near-infrared spectroscopy (NIRS) would be applied to all patients' forehead for consecutively 48 hours after admission.
Inclusion criteria
- Age greater than or equal to 18 years old,
- History of traumatic brain injury,
- Radiological evidence of intracranial haematoma,
- Glasgow Coma Scale (GCS) less than 15 upon admission,
- Not undergoing immediate operation,
- Admission to the general ward or high dependence unit of Neurosurgery, Prince of Wales Hospital.
Exclusion criteria
- Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,
- Presence of pneumocephale,
- Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.
- Patients who have joined other drug trial in the last four weeks;
- Pregnant or on breast feeding;
- Any other reasons that the researchers consider unsuitable.
Primary outcome - Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.
Secondary outcomes
- Secondary outcome including number of CT scan performed, correlation of NIRS reading with Glasgow coma scale (GCS), rate of intervention with either medical treatment such as use of mannitol, Transamin or blood product transfusion, or surgical treatment such as operation, 30 days mortality and functional outcome at 3 months.
Purpose and Potential:
Near-infrared spectroscopy (NIRS) can offer continuous neuro-monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. This allows early detection of delayed haematoma for early intervention. At the same time, the use of NIRS can potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources.
- Conditions
- Traumatic Brain Injury, Intracerebral Hemorrhage
- Being tested
- Near infrared spectroscopy
- Keywords
- non-invasive monitoring; near-infrared spectroscopy; traumatic brain injury; cerebral contusion
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Brain Contusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDevice
All patients would be receiving the same treatment including application of non-invasive monitoring with near-infrared spectroscopy (NIRS) together with the standard of care with interval CT Brain scan for all patients.
Non-invasive monitoring with near-infrared spectroscopy (NIRS) is very safe and is in current daily routine clinical use for intraoperative patients.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury with cerebral contusions | Not described Receives: Device: Near infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient
Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.
Measured: 1 week
Secondary outcomes (2)
30 days mortality
30 days mortality
Measured: 30 days
modified Rankin Scale
modified Rankin Scale (mRS) at 3 months. The mRS scale ranges from 0 to 6, in which 0 indicates no disability, while 6 indicates death.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Apr 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Yuen Chung CHAN, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653728
- Sponsor's protocol ID
- NTEC-2018-0106
- Status last verified
- Jul 2021
- First submitted
- 28 Aug 2018
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folkerson LE, Sloan D, Cotton BA, Holcomb JB, Tomasek JS, Wade CE. Predicting progressive hemorrhagic injury from isolated traumatic brain injury and coagulation. Surgery. 2015 Sep;158(3):655-61. doi: 10.1016/j.surg.2015.02.029. Epub 2015 Jun 9.
PubMed 26067457Oertel M, Kelly DF, McArthur D, Boscardin WJ, Glenn TC, Lee JH, Gravori T, Obukhov D, McBride DQ, Martin NA. Progressive hemorrhage after head trauma: predictors and consequences of the evolving injury. J Neurosurg. 2002 Jan;96(1):109-16. doi: 10.3171/jns.2002.96.1.0109.
PubMed 11794591Narayan RK, Maas AI, Servadei F, Skolnick BE, Tillinger MN, Marshall LF; Traumatic Intracerebral Hemorrhage Study Group. Progression of traumatic intracerebral hemorrhage: a prospective observational study. J Neurotrauma. 2008 Jun;25(6):629-39. doi: 10.1089/neu.2007.0385.
PubMed 18491950Alahmadi H, Vachhrajani S, Cusimano MD. The natural history of brain contusion: an analysis of radiological and clinical progression. J Neurosurg. 2010 May;112(5):1139-45. doi: 10.3171/2009.5.JNS081369.
PubMed 19575576Weigl W, Milej D, Janusek D, Wojtkiewicz S, Sawosz P, Kacprzak M, Gerega A, Maniewski R, Liebert A. Application of optical methods in the monitoring of traumatic brain injury: A review. J Cereb Blood Flow Metab. 2016 Nov;36(11):1825-1843. doi: 10.1177/0271678X16667953. Epub 2016 Sep 7.
PubMed 27604312Kim B, Jeong H, Kim J, Kim T, Kim K, Lee H, Ahn S, Jo YH, Lee JH, Hwang JE. Incidence and risk factors of delayed intracranial hemorrhage in the emergency department. Am J Emerg Med. 2018 Feb;36(2):271-276. doi: 10.1016/j.ajem.2017.08.009. Epub 2017 Aug 4.
PubMed 28811212Chieregato A, Fainardi E, Morselli-Labate AM, Antonelli V, Compagnone C, Targa L, Kraus J, Servadei F. Factors associated with neurological outcome and lesion progression in traumatic subarachnoid hemorrhage patients. Neurosurgery. 2005 Apr;56(4):671-80; discussion 671-80. doi: 10.1227/01.neu.0000156200.76331.7a.
PubMed 15792505Chang EF, Meeker M, Holland MC. Acute traumatic intraparenchymal hemorrhage: risk factors for progression in the early post-injury period. Neurosurgery. 2006 Apr;58(4):647-56; discussion 647-56. doi: 10.1227/01.NEU.0000197101.68538.E6.
PubMed 16575328Poon WS, Wong GK, Ng SC. The quantitative time-resolved near infrared spectroscopy (TR-NIRs) for bedside cerebrohemodynamic monitoring after aneurysmal subarachnoid hemorrhage: can we predict delayed neurological deficits? World Neurosurg. 2010 May;73(5):465-6. doi: 10.1016/j.wneu.2010.03.029. No abstract available.
PubMed 20920925Gomersall CD, Leung PL, Gin T, Joynt GM, Young RJ, Poon WS, Oh TE. A comparison of the Hamamatsu NIRO 500 and the INVOS 3100 near-infrared spectrophotometers. Anaesth Intensive Care. 1998 Oct;26(5):548-57. doi: 10.1177/0310057X9802600512.
PubMed 9807611Gomersall CD, Joynt GM, Gin T, Freebairn RC, Stewart IE. Failure of the INVOS 3100 cerebral oximeter to detect complete absence of cerebral blood flow. Crit Care Med. 1997 Jul;25(7):1252-4. doi: 10.1097/00003246-199707000-00031. No abstract available.
PubMed 9233756
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neuro-monitoring for Head Injury: Use of Near Infra-red Spectroscopy for Early Detection of Delayed Intracranial Haematoma
- ClinicalTrials.gov ID
- NCT03653728
- Acronym / sponsor ID
- NTEC-2018-0106
- Conditions
- Traumatic Brain Injury, Intracerebral Hemorrhage
- Keywords
- non-invasive monitoring; near-infrared spectroscopy; traumatic brain injury; cerebral contusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 31 Aug 2018 (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.
Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.
Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these noninvasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources. Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as nearinfrared spectroscopy (NIRS) is to be investigated.
The aim of this study is to determine the sensitivity and specificity of NIRS as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain. Study design is Prospective sensitivity and specificity study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited. Outcome measures including correlation of non-invasive monitoring with near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect. Secondary outcome including 30 days mortality and functional outcome at 3 months.
Detailed description
Introduction: Fall with head injury is becoming an epidemic challenge especially with the ageing population. Contributing factors for mortality and poor functional outcome included development of cerebral contusion and delayed traumatic intracerebral haematoma. There is a higher prevalence especially with the increasing use of antiplatelets and anticoagulants.
Non-invasive monitoring such as near-infrared spectroscopy (NIRS) is sensitive in detecting intracranial changes. The role and efficacy of this non-invasive method has not been specifically established in patients with head injury as an initial non-operative monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. The advantages of these non-invasive monitoring might have a role of continuous neuro-monitoring. They can also potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources.
Timely detection and treatment of this condition accordingly is crucial. Potential options of non-invasive monitoring such as near-infrared spectroscopy (NIRS) is to be investigated.
Aims and Hypotheses to be tested:
The aim of this study is to determine the sensitivity and specificity of near-infrared spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain.
Plan of Investigation:
This is a prospective sensitivity and specificity correlation study of Near Infra-red Spectroscopy (NIRS) as a non-invasive monitoring in detecting delayed intracranial injuries in comparison with the Gold Standard CT Brain in Hong Kong Chinese. Consecutive patients admitted to Prince of Wales Hospital, Hong Kong would be recruited.
Consecutive patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS). Criteria to proceed for repeat CT Brain scan 1) clinical deterioration of GCS >2 points, 2) NIRS monitoring has increase in difference in absorbance of light at 760nm >0.3, or 3) 8 hours after admission for baseline interval scan for all patients as part of the standard of care. Non-invasive monitoring with near-infrared spectroscopy (NIRS) would be applied to all patients' forehead for consecutively 48 hours after admission.
Inclusion criteria
- Age greater than or equal to 18 years old,
- History of traumatic brain injury,
- Radiological evidence of intracranial haematoma,
- Glasgow Coma Scale (GCS) less than 15 upon admission,
- Not undergoing immediate operation,
- Admission to the general ward or high dependence unit of Neurosurgery, Prince of Wales Hospital.
Exclusion criteria
- Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,
- Presence of pneumocephale,
- Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.
- Patients who have joined other drug trial in the last four weeks;
- Pregnant or on breast feeding;
- Any other reasons that the researchers consider unsuitable.
Primary outcome - Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.
Secondary outcomes
- Secondary outcome including number of CT scan performed, correlation of NIRS reading with Glasgow coma scale (GCS), rate of intervention with either medical treatment such as use of mannitol, Transamin or blood product transfusion, or surgical treatment such as operation, 30 days mortality and functional outcome at 3 months.
Purpose and Potential:
Near-infrared spectroscopy (NIRS) can offer continuous neuro-monitoring. This is particular important in the setting of a general ward in which nursing staff is limited. This allows early detection of delayed haematoma for early intervention. At the same time, the use of NIRS can potentially reduce the number of unnecessary repeated CT Brain in the context of limited radiology staff and resources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury with cerebral contusions | – | Device: Near infrared spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive traumatic brain injury patients fulfilling the inclusion and exclusion criteria are treated with standard of care with near-infrared spectroscopy (NIRS).
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years old,
- History of traumatic brain injury,
- Radiological evidence of intracranial haematoma,
- Glasgow Coma Scale (GCS) less than 15 upon admission,
- Not undergoing immediate operation,
Key exclusion criteria (6 listed)
- Presence of frontal scalp laceration preventing the application of non-invasive monitoring on the forehead,
- Presence of pneumocephale,
- Requirement of immediate surgical intervention as judged by the on-call neurosurgeon.
- Patients who have joined other drug trial in the last four weeks;
- Pregnant or on breast feeding;
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 |
|---|---|---|
| Near infrared spectroscopyAll patients would be receiving the same treatment including application of non-invasive monitoring with near-infrared spectroscopy (NIRS) together with the standard of care with interval CT Brain scan for all patients. Non-invasive monitoring with near-infrared spectroscopy (NIRS) is very safe and is in current daily routine clinical use for intraoperative patients. | Device | Traumatic brain injury with cerebral contusions |
Primary outcome
Correlation coefficient
Time frame: 1 week
Correlation coefficient of near-infrared spectroscopy (NIRS) to CT Brain findings including any increase in haematoma size, cerebral edema or mass effect.
2 secondary outcomes
30 days mortality
Time frame: 30 days
modified Rankin Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 26067457Folkerson LE, Sloan D, Cotton BA, Holcomb JB, Tomasek JS, Wade CE. Predicting progressive hemorrhagic injury from isolated traumatic brain injury and coagulation. Surgery. 2015 Sep;158(3):655-61. doi: 10.1016/j.surg.2015.02.029. Epub 2015 Jun 9.
- Background: PubMed 11794591Oertel M, Kelly DF, McArthur D, Boscardin WJ, Glenn TC, Lee JH, Gravori T, Obukhov D, McBride DQ, Martin NA. Progressive hemorrhage after head trauma: predictors and consequences of the evolving injury. J Neurosurg. 2002 Jan;96(1):109-16. doi: 10.3171/jns.2002.96.1.0109.
- Background: PubMed 18491950Narayan RK, Maas AI, Servadei F, Skolnick BE, Tillinger MN, Marshall LF; Traumatic Intracerebral Hemorrhage Study Group. Progression of traumatic intracerebral hemorrhage: a prospective observational study. J Neurotrauma. 2008 Jun;25(6):629-39. doi: 10.1089/neu.2007.0385.
- Background: PubMed 19575576Alahmadi H, Vachhrajani S, Cusimano MD. The natural history of brain contusion: an analysis of radiological and clinical progression. J Neurosurg. 2010 May;112(5):1139-45. doi: 10.3171/2009.5.JNS081369.
- Background: PubMed 27604312Weigl W, Milej D, Janusek D, Wojtkiewicz S, Sawosz P, Kacprzak M, Gerega A, Maniewski R, Liebert A. Application of optical methods in the monitoring of traumatic brain injury: A review. J Cereb Blood Flow Metab. 2016 Nov;36(11):1825-1843. doi: 10.1177/0271678X16667953. Epub 2016 Sep 7.
- Background: PubMed 28811212Kim B, Jeong H, Kim J, Kim T, Kim K, Lee H, Ahn S, Jo YH, Lee JH, Hwang JE. Incidence and risk factors of delayed intracranial hemorrhage in the emergency department. Am J Emerg Med. 2018 Feb;36(2):271-276. doi: 10.1016/j.ajem.2017.08.009. Epub 2017 Aug 4.
- Background: PubMed 15792505Chieregato A, Fainardi E, Morselli-Labate AM, Antonelli V, Compagnone C, Targa L, Kraus J, Servadei F. Factors associated with neurological outcome and lesion progression in traumatic subarachnoid hemorrhage patients. Neurosurgery. 2005 Apr;56(4):671-80; discussion 671-80. doi: 10.1227/01.neu.0000156200.76331.7a.
- Background: PubMed 16575328Chang EF, Meeker M, Holland MC. Acute traumatic intraparenchymal hemorrhage: risk factors for progression in the early post-injury period. Neurosurgery. 2006 Apr;58(4):647-56; discussion 647-56. doi: 10.1227/01.NEU.0000197101.68538.E6.
- Background: PubMed 20920925Poon WS, Wong GK, Ng SC. The quantitative time-resolved near infrared spectroscopy (TR-NIRs) for bedside cerebrohemodynamic monitoring after aneurysmal subarachnoid hemorrhage: can we predict delayed neurological deficits? World Neurosurg. 2010 May;73(5):465-6. doi: 10.1016/j.wneu.2010.03.029. No abstract available.
- Background: PubMed 9807611Gomersall CD, Leung PL, Gin T, Joynt GM, Young RJ, Poon WS, Oh TE. A comparison of the Hamamatsu NIRO 500 and the INVOS 3100 near-infrared spectrophotometers. Anaesth Intensive Care. 1998 Oct;26(5):548-57. doi: 10.1177/0310057X9802600512.
- Background: PubMed 9233756Gomersall CD, Joynt GM, Gin T, Freebairn RC, Stewart IE. Failure of the INVOS 3100 cerebral oximeter to detect complete absence of cerebral blood flow. Crit Care Med. 1997 Jul;25(7):1252-4. doi: 10.1097/00003246-199707000-00031. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
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 Traumatic Brain Injury and Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 6 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 29 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 Hong Kong. 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?
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?
Correlation coefficient (time frame: 1 week). 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 NCT03653728, which also lists 11 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 29 Jul 2021.