TraumaPhase 4BBTBBTNCT04508244
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status
A Phase 4 study testing Propranolol in people with Trauma and Brain Injuries, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Brain Injuries, Stress Reaction
- What is being tested?
- Propranolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 771 participants
- Where
- 1 siteQatar
- Study dates
- 29 Dec 2020to 31 Dec 2024
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (≥18 -65 years)
- both genders
- mild-to-severe blunt TBI (head AIS 1-5 and/ GCS 4-15) patients requiring hospital admission
Who cannot join
- Patients <18 and> 65 yrs old
- penetrating trauma
- non-survivable injuries (head AIS=6 \& GCS=3)
- uncontrolled bleeding on arrival to ED
- pregnant women
- prisoners
Show all 11Show fewer
- patients with heart rate (HR) ≤70, systolic blood pressure (SBP) ≤100 mmHg (or MAP <70 mmHg) not responding to initial management or required to be maintained on vasopressors on arrival .
- Patients who will undergo hypothermia therapy,
- any penetrating injury to head, thorax or abdomen,
- history of bronchial asthma
- patients posted for emergency surgery during the first 6 hrs.
Trial locations and contacts
1 site in 1 country.
Mohammad Asim, PhD contact
Qatar1 site, 1 recruiting
- Recruiting
Hamad General Hospital
Doha
Ayman El-Menyar, MD
About this study
Official title: Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status: A Randomized Controlled Trial (BBTBBT)
Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients.
Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.
Read the detailed description
Traumatic brain injury (TBI) accounts for up to 30% of all injury-related deaths [1]. It also poses a significant morbidity and economic burden world-wide [2,3]. While there has been significant advances in trauma care overall, there are limited medical management options for head injury. Based on retrospective observational studies, TBI is associated with an increased risk of mortality. Some of these studies reported higher rate of mortality in TBI patients who had elevated serum troponin in comparison to those who had normal troponin, even in isolated TBI.
Few studies have evaluated the clinical significance of the release of serum cardiac troponins after trauma [4-7]. Some of these studies showed that elevated troponin could reflect the degree of severity of overall body injury, but in particular the severity of thorax trauma regardless of cardiac involvement [5,6]. Furthermore, elevated troponins were reported in acute non-traumatic head injury, including acute stroke (≈27%), and subarachnoid hemorrhage (≈20%) [4, 7]. However, the precise mechanism of elevated troponin is difficult to be determined due to the multitude of prevailing clinical circumstances which may influence troponin release. Moreover, the clinical significance and prognostic value of elevated troponins levels and immune response remain poorly explored in TBI patients. Earlier studies relied mainly on TnT or TnI and did not examine the newer high-sensitive TnT (HsTnT) which has more sensitivity and shorter time to detect myocardial damage. A recent meta-analysis showed that elevated troponins are commonly seen in critically-ill patients even in the absence of coronary artery disease [7,8,9] with a prevalence of 45% studies utilized conventional troponin assays ( TnT and TnI), [10] however, this figure reaches 62% with the use of HsTnT [11, 12]. From the therapeutic point of view, BBs use was reported to have better survival in blunt TBI patients [4, 14, 15,16]. Notably, BBs play an important role in protection of end organs that are susceptible for secondary injury by the TBI-induced catecholamine surge [4]. Upon the latter observation, the use of HsTnT test early in TBI cases may allow early stratification and therapy to possibly reduce mortality. However, this assumption needs further support through large clinical trials. Prospective studies that link the release of troponins and mortality in post-TBI patients are lacking. The use of BBs in patients with acute coronary myocardial injury is evidence-based, especially in the very early hours post myocardial injury. However, use of BBs in trauma patients is not yet the standard of care. The use of BBs needs to be clearly justified in TBI patients. Retrospectively, Salim et al [13] reported that patients with severe TBI who did not receive BBs had a mortality rate of 36% vs. 24% in those who were receiving BBs (p=0.036). Furthermore, if troponin I was elevated on admission, the hospital mortality increased to 48.5% in patients without BBs therapy vs. 22.4% in those who were using BBs (p=0.026).However, the two groups (with \& without BB) were comparable for mortality, if the admission troponin values were not elevated (p=0.31). In brief, the utmost benefit in survival occurred in BBs use group based on the troponin positivity on admission. However, this study did not explain the specific underlying mechanism of troponin positivity. The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status. We hypothesized that early administration of BBs has beneficial effect on the 10 and 30-day mortality in patients with mild-to-severe TBI based on the admission HsTnT status.
- Conditions
- Trauma, Brain Injuries, Stress Reaction, Beta Blockers, Troponin
- Being tested
- Placebo, Propranolol
- Keywords
- propranolol, troponin, biomarkers, myocardial injury, brain injury, trauma, qatar
- Medical subject headings
- Wounds and Injuries, Brain Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6.
PropranololDrug
Also called inderal
12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6.
| Study group | Role | What they receive |
|---|---|---|
| TBI with positive troponin | Active comparator | Patients will receive IV propranolol for 6 days Receives: Drug: Propranolol |
| TBI with negative troponin (a) | Placebo comparator | Patients will receive IV placebol for 6 days Receives: Drug: Placebo |
| TBI with negative troponin (b) | Experimental | Patients will receive IV propranolol for 6 days Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of participants who died from each study arm
Measured: 10 days
Mortality
Number of participants who died from each study arm
Measured: 30 days
Secondary outcomes (2)
Duration of hospital stay
number of days in the hospital
Measured: 3 months
Functional status
Glasgow Outcome scale (range 1-8); higher scores mean a better outcome
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 posted11 Aug 2020
- Study start29 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blinded, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 771 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayman El-Menyar, MD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508244
- Sponsor's protocol ID
- IRGC-05-SI-18-293
- Acronym
- BBTBBT
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data sharing agreement should be signed with the MRC and legal affair at HMC
Publications
Faul M, Xu L, Wald MM, Coronado VG. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2010.
Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.
PubMed 24462839Mock C, Lormand JD, Goosen J, Joshipura M, Peden M. Guidelines for essential trauma care. Geneva, World Health Organization, 2004. Retrieved from: http://www.who.int/violence_injury_prevention/publications/services/en/guidelines_traumacare.pdf
Al-Otaiby MA, Al-Amri HS, Al-Moghairi AM. The clinical significance of cardiac troponins in medical practice. J Saudi Heart Assoc. 2011 Jan;23(1):3-11. doi: 10.1016/j.jsha.2010.10.001. Epub 2010 Oct 20.
PubMed 23960628Mahmood I, El-Menyar A, Dabdoob W, Abdulrahman Y, Siddiqui T, Atique S, Arumugam SK, Latifi R, Al-Thani H. Troponin T in Patients with Traumatic Chest Injuries with and without Cardiac Involvement: Insights from an Observational Study. N Am J Med Sci. 2016 Jan;8(1):17-24. doi: 10.4103/1947-2714.175188.
PubMed 27011943Edouard AR, Felten ML, Hebert JL, Cosson C, Martin L, Benhamou D. Incidence and significance of cardiac troponin I release in severe trauma patients. Anesthesiology. 2004 Dec;101(6):1262-8. doi: 10.1097/00000542-200412000-00004.
PubMed 15564931Hasanin A, Kamal A, Amin S, Zakaria D, El Sayed R, Mahmoud K, Mukhtar A. Incidence and outcome of cardiac injury in patients with severe head trauma. Scand J Trauma Resusc Emerg Med. 2016 Apr 27;24:58. doi: 10.1186/s13049-016-0246-z.
PubMed 27121183Smith A, John M, Trout R, Davis E, Moningi S. Elevated cardiac troponins in sepsis: what do they signify? W V Med J. 2009 Jul-Aug;105(4):29-32.
PubMed 19585902Lim W, Cook DJ, Griffith LE, Crowther MA, Devereaux PJ. Elevated cardiac troponin levels in critically ill patients: prevalence, incidence, and outcomes. Am J Crit Care. 2006 May;15(3):280-8; quiz 289.
PubMed 16632770Poe S, Vandivier-Pletsch RH, Clay M, Wong HR, Haynes E, Rothenberg FG. Cardiac Troponin Measurement in the Critically Ill: Potential for Guiding Clinical Management. J Investig Med. 2015 Dec;63(8):905-15. doi: 10.1097/JIM.0000000000000239.
PubMed 26425879Salim A, Hadjizacharia P, Brown C, Inaba K, Teixeira PG, Chan L, Rhee P, Demetriades D. Significance of troponin elevation after severe traumatic brain injury. J Trauma. 2008 Jan;64(1):46-52. doi: 10.1097/TA.0b013e31815eb15a.
PubMed 18188098Bukur M, Mohseni S, Ley E, Salim A, Margulies D, Talving P, Demetriades D, Inaba K. Efficacy of beta-blockade after isolated blunt head injury: does race matter? J Trauma Acute Care Surg. 2012 Apr;72(4):1013-8. doi: 10.1097/TA.0b013e318241bc5b.
PubMed 22491619Schroeppel TJ, Fischer PE, Zarzaur BL, Magnotti LJ, Clement LP, Fabian TC, Croce MA. Beta-adrenergic blockade and traumatic brain injury: protective? J Trauma. 2010 Oct;69(4):776-82. doi: 10.1097/TA.0b013e3181e981b8.
PubMed 20938265Ko A, Harada MY, Barmparas G, Thomsen GM, Alban RF, Bloom MB, Chung R, Melo N, Margulies DR, Ley EJ. Early propranolol after traumatic brain injury is associated with lower mortality. J Trauma Acute Care Surg. 2016 Apr;80(4):637-42. doi: 10.1097/TA.0000000000000959.
PubMed 26808028El-Menyar A, Asim M, Latifi R, Bangdiwala SI, Al-Thani H. Predictive value of positive high-sensitivity troponin T in intubated traumatic brain injury patients. J Neurosurg. 2018 Dec 1;129(6):1541-1549. doi: 10.3171/2017.7.JNS17675. Epub 2018 Jan 5.
PubMed 29303440
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status: A Randomized Controlled Trial (BBTBBT)
- ClinicalTrials.gov ID
- NCT04508244
- Acronym / sponsor ID
- BBTBBT / IRGC-05-SI-18-293
- Conditions
- Trauma, Brain Injuries, Stress Reaction, Beta Blockers, Troponin
- Keywords
- propranolol, troponin, biomarkers, myocardial injury, brain injury, trauma, qatar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 771 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Aug 2020 (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.
Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients.
Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.
Detailed description
Traumatic brain injury (TBI) accounts for up to 30% of all injury-related deaths [1]. It also poses a significant morbidity and economic burden world-wide [2,3]. While there has been significant advances in trauma care overall, there are limited medical management options for head injury. Based on retrospective observational studies, TBI is associated with an increased risk of mortality. Some of these studies reported higher rate of mortality in TBI patients who had elevated serum troponin in comparison to those who had normal troponin, even in isolated TBI.
Few studies have evaluated the clinical significance of the release of serum cardiac troponins after trauma [4-7]. Some of these studies showed that elevated troponin could reflect the degree of severity of overall body injury, but in particular the severity of thorax trauma regardless of cardiac involvement [5,6]. Furthermore, elevated troponins were reported in acute non-traumatic head injury, including acute stroke (≈27%), and subarachnoid hemorrhage (≈20%) [4, 7]. However, the precise mechanism of elevated troponin is difficult to be determined due to the multitude of prevailing clinical circumstances which may influence troponin release. Moreover, the clinical significance and prognostic value of elevated troponins levels and immune response remain poorly explored in TBI patients. Earlier studies relied mainly on TnT or TnI and did not examine the newer high-sensitive TnT (HsTnT) which has more sensitivity and shorter time to detect myocardial damage. A recent meta-analysis showed that elevated troponins are commonly seen in critically-ill patients even in the absence of coronary artery disease [7,8,9] with a prevalence of 45% studies utilized conventional troponin assays ( TnT and TnI), [10] however, this figure reaches 62% with the use of HsTnT [11, 12]. From the therapeutic point of view, BBs use was reported to have better survival in blunt TBI patients [4, 14, 15,16]. Notably, BBs play an important role in protection of end organs that are susceptible for secondary injury by the TBI-induced catecholamine surge [4]. Upon the latter observation, the use of HsTnT test early in TBI cases may allow early stratification and therapy to possibly reduce mortality. However, this assumption needs further support through large clinical trials. Prospective studies that link the release of troponins and mortality in post-TBI patients are lacking. The use of BBs in patients with acute coronary myocardial injury is evidence-based, especially in the very early hours post myocardial injury. However, use of BBs in trauma patients is not yet the standard of care. The use of BBs needs to be clearly justified in TBI patients. Retrospectively, Salim et al [13] reported that patients with severe TBI who did not receive BBs had a mortality rate of 36% vs. 24% in those who were receiving BBs (p=0.036). Furthermore, if troponin I was elevated on admission, the hospital mortality increased to 48.5% in patients without BBs therapy vs. 22.4% in those who were using BBs (p=0.026).However, the two groups (with \& without BB) were comparable for mortality, if the admission troponin values were not elevated (p=0.31). In brief, the utmost benefit in survival occurred in BBs use group based on the troponin positivity on admission. However, this study did not explain the specific underlying mechanism of troponin positivity. The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status. We hypothesized that early administration of BBs has beneficial effect on the 10 and 30-day mortality in patients with mild-to-severe TBI based on the admission HsTnT status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Prospective, randomized, double-blinded, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| TBI with positive troponin | Active comparator | Drug: PropranololPatients will receive IV propranolol for 6 days |
| TBI with negative troponin (a) | Placebo comparator | Drug: PlaceboPatients will receive IV placebol for 6 days |
| TBI with negative troponin (b) | Experimental | Drug: PropranololPatients will receive IV propranolol for 6 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adults (≥18 -65 years)
- both genders
- mild-to-severe blunt TBI (head AIS 1-5 and/ GCS 4-15) patients requiring hospital admission
Key exclusion criteria (11 listed)
- Patients <18 and> 65 yrs old
- penetrating trauma
- non-survivable injuries (head AIS=6 \& GCS=3)
- uncontrolled bleeding on arrival to ED
- pregnant women
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 |
|---|---|---|
| Placebo12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6. | Drug | TBI with negative troponin (a) |
| PropranololAlso: inderal12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6. | Drug | TBI with negative troponin (b), TBI with positive troponin |
Primary outcome
Mortality
Time frame: 10 days
Number of participants who died from each study arm
Mortality
Time frame: 30 days
Number of participants who died from each study arm
2 secondary outcomes
Duration of hospital stay
Time frame: 3 months
Functional status
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 28 Sep 2023.
- BackgroundFaul M, Xu L, Wald MM, Coronado VG. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2010.
- Background: PubMed 24462839Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.
- BackgroundMock C, Lormand JD, Goosen J, Joshipura M, Peden M. Guidelines for essential trauma care. Geneva, World Health Organization, 2004. Retrieved from: http://www.who.int/violence_injury_prevention/publications/services/en/guidelines_traumacare.pdf
- Background: PubMed 23960628Al-Otaiby MA, Al-Amri HS, Al-Moghairi AM. The clinical significance of cardiac troponins in medical practice. J Saudi Heart Assoc. 2011 Jan;23(1):3-11. doi: 10.1016/j.jsha.2010.10.001. Epub 2010 Oct 20.
- Background: PubMed 27011943Mahmood I, El-Menyar A, Dabdoob W, Abdulrahman Y, Siddiqui T, Atique S, Arumugam SK, Latifi R, Al-Thani H. Troponin T in Patients with Traumatic Chest Injuries with and without Cardiac Involvement: Insights from an Observational Study. N Am J Med Sci. 2016 Jan;8(1):17-24. doi: 10.4103/1947-2714.175188.
- Background: PubMed 15564931Edouard AR, Felten ML, Hebert JL, Cosson C, Martin L, Benhamou D. Incidence and significance of cardiac troponin I release in severe trauma patients. Anesthesiology. 2004 Dec;101(6):1262-8. doi: 10.1097/00000542-200412000-00004.
- Background: PubMed 27121183Hasanin A, Kamal A, Amin S, Zakaria D, El Sayed R, Mahmoud K, Mukhtar A. Incidence and outcome of cardiac injury in patients with severe head trauma. Scand J Trauma Resusc Emerg Med. 2016 Apr 27;24:58. doi: 10.1186/s13049-016-0246-z.
- Background: PubMed 19585902Smith A, John M, Trout R, Davis E, Moningi S. Elevated cardiac troponins in sepsis: what do they signify? W V Med J. 2009 Jul-Aug;105(4):29-32.
- Background: PubMed 16632770Lim W, Cook DJ, Griffith LE, Crowther MA, Devereaux PJ. Elevated cardiac troponin levels in critically ill patients: prevalence, incidence, and outcomes. Am J Crit Care. 2006 May;15(3):280-8; quiz 289.
- Background: PubMed 26425879Poe S, Vandivier-Pletsch RH, Clay M, Wong HR, Haynes E, Rothenberg FG. Cardiac Troponin Measurement in the Critically Ill: Potential for Guiding Clinical Management. J Investig Med. 2015 Dec;63(8):905-15. doi: 10.1097/JIM.0000000000000239.
- Background: PubMed 18188098Salim A, Hadjizacharia P, Brown C, Inaba K, Teixeira PG, Chan L, Rhee P, Demetriades D. Significance of troponin elevation after severe traumatic brain injury. J Trauma. 2008 Jan;64(1):46-52. doi: 10.1097/TA.0b013e31815eb15a.
- Background: PubMed 22491619Bukur M, Mohseni S, Ley E, Salim A, Margulies D, Talving P, Demetriades D, Inaba K. Efficacy of beta-blockade after isolated blunt head injury: does race matter? J Trauma Acute Care Surg. 2012 Apr;72(4):1013-8. doi: 10.1097/TA.0b013e318241bc5b.
- Individual participant dataSharing planned: No. data sharing agreement should be signed with the MRC and legal affair at HMC
Related trials for Trauma
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
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.
Mohammad Asim, PhD contact
Ayman El-Menyar, MD principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol in people with Trauma and Brain Injuries, run by Hamad Medical Corporation at 1 site in Qatar.
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 11 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 28 Sep 2023. 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 Qatar. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ayman El-Menyar, MD (44396130, aelmenyar@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 10 days). 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 NCT04508244, which also lists 18 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 28 Sep 2023.