Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648369
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAX-ICH
Brief Summary:
The MAX-ICH pilot trial is a phase-II study aimed at assessing the feasibility and safety of a comprehensive care bundle for patients with intracerebral hemorrhage ICH This maximal medical treatment approach combines advanced interventions like intensive blood pressure control rapid anticoagulation reversal and tranexamic acid administration to potentially improve outcomes The primary objective is to evaluate recruitment feasibility over 12 months while secondary objectives include protocol adherence safety monitoring and the exploration of clinical outcomes The study focuses on the critical first 72 hours of care to determine if this approach can be effectively implemented in clinical practice
Detailed Description:
The MAX-ICH pilot trial is a monocentric phase-II study designed to evaluate the feasibility and safety of a maximal medical treatment care bundle for patients suffering from intracerebral hemorrhage ICH ICH is a condition with a notably high rate of mortality and morbidity and this trial aims to improve outcomes for these patients by utilizing a comprehensive approach to their treatment Previous clinical trials concentrated on single interventions such as blood pressure control and the administration of tranexamic acid TXA therapy While these interventions did not achieve their primary efficacy outcomes they did demonstrate beneficial effects on secondary measures like reducing hematoma expansion and early mortality The current study builds on this prior research by integrating advanced interventions into a unified and comprehensive care bundle termed MAX-ICH with the goal of potentially enhancing patient outcomes
The primary objective of the trial is to demonstrate the feasibility of recruiting patients within a 12-month period In addition to this secondary objectives include assessing the technical feasibility of protocol adherence targeting a compliance rate of at least 70 The study will also monitor safety by tracking major adverse cardiovascular events MACE and explore a range of clinical outcomes treatment metrics and differences between the experimental group receiving the MAX-ICH care bundle and those receiving standard care
The MAX-ICH care bundle consists of several key components designed to deliver intensive and timely care Patients will receive 72 hours of treatment in a high-dependency unit ensuring continuous monitoring and rapid responses to any changes in their condition Intensive blood pressure control will be implemented through intra-arterial monitoring to maintain stability If a patient is on anticoagulant therapy the care bundle mandates rapid reversal of anticoagulation within 60 minutes of presentation Similarly tranexamic acid will be administered within 60 minutes helping to mitigate further hemorrhage Neurosurgical evaluation will also be conducted within 60 minutes to determine if surgical intervention is warranted Additionally counseling will be provided to avoid placing Do-Not-Resuscitate DNR orders during the critical first 72 hours allowing time for the intensive interventions to take effect
Ultimately this study aims to determine whether the MAX-ICH care bundle can be feasibly implemented in clinical practice and whether its structured intensive approach within the first 72 hours of care can lead to improved outcomes for patients with ICH
The primary objective of the trial is to demonstrate the feasibility of recruiting patients within a 12-month period In addition to this secondary objectives include assessing the technical feasibility of protocol adherence targeting a compliance rate of at least 70 The study will also monitor safety by tracking major adverse cardiovascular events MACE and explore a range of clinical outcomes treatment metrics and differences between the experimental group receiving the MAX-ICH care bundle and those receiving standard care
The MAX-ICH care bundle consists of several key components designed to deliver intensive and timely care Patients will receive 72 hours of treatment in a high-dependency unit ensuring continuous monitoring and rapid responses to any changes in their condition Intensive blood pressure control will be implemented through intra-arterial monitoring to maintain stability If a patient is on anticoagulant therapy the care bundle mandates rapid reversal of anticoagulation within 60 minutes of presentation Similarly tranexamic acid will be administered within 60 minutes helping to mitigate further hemorrhage Neurosurgical evaluation will also be conducted within 60 minutes to determine if surgical intervention is warranted Additionally counseling will be provided to avoid placing Do-Not-Resuscitate DNR orders during the critical first 72 hours allowing time for the intensive interventions to take effect
Ultimately this study aims to determine whether the MAX-ICH care bundle can be feasibly implemented in clinical practice and whether its structured intensive approach within the first 72 hours of care can lead to improved outcomes for patients with ICH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None