Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508244
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2020-07-24
Brief Title:
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status A Randomized Controlled Trial BBTBBT
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBTBBT
Brief 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 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 patientsBBs are effective in reducing 10 and 30-day mortality in TBI patients
MethodsDesign 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
MethodsDesign 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 23 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 56 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 789 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 1516 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 p0036 Furthermore if troponin I was elevated on admission the hospital mortality increased to 485 in patients without BBs therapy vs 224 in those who were using BBs p0026However the two groups with without BB were comparable for mortality if the admission troponin values were not elevated p031 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
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 56 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 789 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 1516 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 p0036 Furthermore if troponin I was elevated on admission the hospital mortality increased to 485 in patients without BBs therapy vs 224 in those who were using BBs p0026However the two groups with without BB were comparable for mortality if the admission troponin values were not elevated p031 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None