Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337838
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-22
Brief Title:
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery BRACKETS Pilot Trial
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
Bleeding Reduction in Acute and Chronic KidnEy patienTs Having Surgery BRACKETS Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
BRACKETS
Brief Summary:
The BRACKETS pilot study is a multicentre prospective randomized controlled trial of prophylactic preoperative tranexamic acid TXA versus placebo and using a partial factorial design of prophylactic preoperative desmopressin versus placebo
Detailed Description:
Perioperative administration of TXA reduces bleeding risk in surgical patients However large clinical trials have excluded patients with advanced kidney disease so the benefits remain uncertain in this population and there is potential for harm The benefit of desmopressin which is purported to more directly address the defect of primary hemostasis believed important in severe kidney disease more directly than TXA has not been examined in adequate randomized control trials RCTs Both medications are generic and have been available for many years To convincingly test these medications in patients with severe kidney disease large global trials are required This pilot-phase trial will 1 inform the feasibility and design of a large international trial to evaluate the efficacy and safety of TXA and desmopressin in patients with severe kidney disease undergoing noncardiac surgery 2 provide preliminary data regarding the efficacy and safety of TXA and desmopressin in people with advanced kidney disease having noncardiac surgery and 3 provide pharmacokinetic data to inform dose selection
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