Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575517
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants IMPACT-BLEEDING
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants IMPACT-BLEEDING a Cluster-randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Prospective cluster randomized trial including expected 168 patients with chronic use of oral anticoagulation OAC suffering major bleeding Randomization will be performed stratified by geographic region SouthernSoutheastern Brazil versus other Brazilian regions
Detailed Description:
The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding including transfusion thresholds and when indicated laboratory assessment of coagulation when indicated reversal agents when indicated and tailored approach to restarting of oral anticoagulation and dosing adjustments among patients after bleeding episode This bundle will be based on a society guideline on bleeding management from the American College of Cardiology The Group 2 will be randomized to the standard of care Standard of care will be left to the discretion of the sites clusters participating in the study All sites including those from the control group will be encouraged to follow local policies of blood product utilization and bleeding management
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