Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-14
Brief Title:
International Care Bundle Evaluation in Cerebral Hemorrhage Research
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
I-CATCHER
Brief Summary:
Spontaneous intracerebral haemorrhage ICH accounts for approximately 10-15 of all strokes but stands for 50 of stroke-related morbidity and mortality Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission Despite this intensive care and neurosurgical interventions are uncommon A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering as well as the treatment of pyrexia and elevated blood glucose levels The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia as well as in other high-income countries The study has a clear focus on implementation aiming to improve treatment and prognosis for patients with ICH within a few years The purpose of I-CATCHER is to investigate whether a structured treatment package Care Bundle improves 3-month prognosis in patients with spontaneous ICH compared to standard care
Detailed Description:
Spontaneous intracerebral hemorrhage ICH accounts for 10 to 15 of all strokes in high-income countries HIC and nearly twice this number in low-income to upper-middle-income countries LMIC 295 It is the most devastating type of stroke given the high one-month case fatality of approximately 30-40 and only 12-39 suffer persistent disability
Despite several advances in the management of acute ischemic stroke supported by numerous randomized controlled trials RCT progress in establishing novel interventions to improve outcomes for ICH has been slow Still today the diagnosis of ICH evokes pessimism among treating physicians and patients may be withheld guideline adherent treatment for this reason This nihilistic approach is presumably due to an over-estimation of poor outcome often influenced by the neurologically devastating features commonly present at ICH admission Additionally the scarcity of RCTs providing strong evidence for treatment recommendations may contribute to a more reluctant approach in the acute setting of ICH particularly when presenting with debilitating symptoms
The third INTEnsive care bundle with BP reduction in acute cerebral hemorrhage trial INTERACT3 was recently published in 2023 This trial employed a stepped wedge cluster RCT design to evaluate the implementation of a Care Bundle protocol This comprehensive protocol included early intensive BP lowering EIBPL management of pyrexia and hyperglycemia and the early reversal of OAC treatment The design of this trial drew inspiration from a post-hoc analysis of the INTERACT2 study that showed that the scoring of abnormal baseline variables interventions included in the future INTERACT3 Care Bundle independently predicted a poor functional outcome following ICH The implementation of the time sensitive bundle of care in INTERACT3 resulted in an improved functional outcome at 6 months following ICH However as the trial included patients predominantly from LMIC further studies are warranted to determine if these results are applicable to HIC with a more applicable Care Bundle for these populations An earlier intervention study from the United Kingdom published in 2019 studied a similar quality improvement acute Care Bundle This Care Bundle aimed to improve the speed of treatment delivery access to acute care and decrease case fatality following ICH Despite certain limitations including a non-randomized design this study demonstrated significantly lower mortality rates in patients receiving the Care Bundle versus the pre-implementation standard of care
I-CATCHER is an international multicenter batched parallel cluster randomized clinical trial RCT to assess a multifaceted package of protocols in a broad range of patients with acute ICH In each batch hospitals will be randomized into two groups according to the timing of the intervention Care Bundle over 3 phases phase 1 usual care phase 2 randomized evaluation - to intervention or usual care phase 3 post-implementation follow-up - all hospitals implement the intervention This design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join Compared to a conventional stepped-wedge cluster RCT the intervention effect in this design is less likely to be confounded by background temporal trends as only baseline and parallel comparison data first 2 periods in bold black frame are used to determine the effectiveness of the Care Bundle All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice Each batch period is 18 months 6 months per phase whole study will be rolled out in 25 years
This design involves implementation of an intervention package applied to all patients with ICH as part of routine care Patients are only excluded if they refuse to have details of their management included andor participate in follow-up procedures
Study site inclusion criteria Organized systems of acute stroke care no established comprehensive protocols for the management of ICH suitable location infrastructure and willingness to participate in clinical research suitable numbers of ICH patients at least 30 per year
Patient inclusion criteria Adults 18 years with spontaneous ICH confirmed by imaging and admitted hospital within 24 hours of the onset of symptoms
Despite several advances in the management of acute ischemic stroke supported by numerous randomized controlled trials RCT progress in establishing novel interventions to improve outcomes for ICH has been slow Still today the diagnosis of ICH evokes pessimism among treating physicians and patients may be withheld guideline adherent treatment for this reason This nihilistic approach is presumably due to an over-estimation of poor outcome often influenced by the neurologically devastating features commonly present at ICH admission Additionally the scarcity of RCTs providing strong evidence for treatment recommendations may contribute to a more reluctant approach in the acute setting of ICH particularly when presenting with debilitating symptoms
The third INTEnsive care bundle with BP reduction in acute cerebral hemorrhage trial INTERACT3 was recently published in 2023 This trial employed a stepped wedge cluster RCT design to evaluate the implementation of a Care Bundle protocol This comprehensive protocol included early intensive BP lowering EIBPL management of pyrexia and hyperglycemia and the early reversal of OAC treatment The design of this trial drew inspiration from a post-hoc analysis of the INTERACT2 study that showed that the scoring of abnormal baseline variables interventions included in the future INTERACT3 Care Bundle independently predicted a poor functional outcome following ICH The implementation of the time sensitive bundle of care in INTERACT3 resulted in an improved functional outcome at 6 months following ICH However as the trial included patients predominantly from LMIC further studies are warranted to determine if these results are applicable to HIC with a more applicable Care Bundle for these populations An earlier intervention study from the United Kingdom published in 2019 studied a similar quality improvement acute Care Bundle This Care Bundle aimed to improve the speed of treatment delivery access to acute care and decrease case fatality following ICH Despite certain limitations including a non-randomized design this study demonstrated significantly lower mortality rates in patients receiving the Care Bundle versus the pre-implementation standard of care
I-CATCHER is an international multicenter batched parallel cluster randomized clinical trial RCT to assess a multifaceted package of protocols in a broad range of patients with acute ICH In each batch hospitals will be randomized into two groups according to the timing of the intervention Care Bundle over 3 phases phase 1 usual care phase 2 randomized evaluation - to intervention or usual care phase 3 post-implementation follow-up - all hospitals implement the intervention This design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join Compared to a conventional stepped-wedge cluster RCT the intervention effect in this design is less likely to be confounded by background temporal trends as only baseline and parallel comparison data first 2 periods in bold black frame are used to determine the effectiveness of the Care Bundle All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice Each batch period is 18 months 6 months per phase whole study will be rolled out in 25 years
This design involves implementation of an intervention package applied to all patients with ICH as part of routine care Patients are only excluded if they refuse to have details of their management included andor participate in follow-up procedures
Study site inclusion criteria Organized systems of acute stroke care no established comprehensive protocols for the management of ICH suitable location infrastructure and willingness to participate in clinical research suitable numbers of ICH patients at least 30 per year
Patient inclusion criteria Adults 18 years with spontaneous ICH confirmed by imaging and admitted hospital within 24 hours of the onset of symptoms
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?:
None
Is an FDA AA801 Violation?:
None