Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622564
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid in Open Cardiac Surgery DEPOSITION-2 Pilot 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:
DEPOSITION-2
Brief Summary:
The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery The main questions it aims to answer are
Is it feasible to conduct a larger definitive trial
Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples
Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better
Participants will
Provide written informed consent
Receive tranexamic acid during surgery
Provide blood samples at 5 time points before surgery on arrival in intensive care unit 3 hours after arrival 6 hours after arrival and on the next morning
Is it feasible to conduct a larger definitive trial
Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples
Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better
Participants will
Provide written informed consent
Receive tranexamic acid during surgery
Provide blood samples at 5 time points before surgery on arrival in intensive care unit 3 hours after arrival 6 hours after arrival and on the next morning
Detailed Description:
Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality It results from the blood thinners that are needed for use Intravenous tranexamic acid TxA has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements Although intravenous TxA is usually well tolerated there is a well-known risk 1 to 4 of postoperative seizures This is due to the similarity between TxA and the brain tissues The aim is to eliminate the risk of seizures and to improve the protection against bleeding When TxA is used before and during cardiopulmonary bypass CPB the presence of systemic TxA during de-airing of the heart and the termination of CPB may facilitate entry of TxA into the brain causing seizures Administration of TxA after CPB may result in higher systemic concentrations that may be more effective for protecting against bleeding after surgery The aim is to establish the feasibility of a definitive trial to prove that administration of TxA after CPB can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery
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