Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04061798
Status:
TERMINATED
Last Update Posted:
2024-02-20
First Post:
2019-08-18
Brief Title:
ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair
Sponsor:
Dijklander Ziekenhuis
Organization:
Dijklander Ziekenhuis
Study Overview
Official Title:
ACTION-1 ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair a Randomised Trial
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTION-1
Brief Summary:
Aim of the ACTION-1 study is to determine whether ACT guided heparinization decreases thrombo-embolic complications TEC and mortality after elective open AAA surgery without causing more bleeding complications
Detailed Description:
Heparin is used during open abdominal aortic aneurysm AAA surgery to reduce thrombo-embolic complications TEC such as myocardial infarction stroke peripheral embolic events and the related mortality On the other hand heparin may increase blood loss causing harm for the patient
Heparin has an unpredictable effect in the individual patient The effect of heparin can be measured by using the Activated Clotting Time ACT ACT measurement in open AAA repair could be introduced to ensure the individual patient of safe tailor-made anticoagulation with a goal ACT of 200-220 seconds A randomized controlled trial RCT has to prove that ACT guided heparinization would result in fewer TEC and lower mortality than a standardized bolus of heparin of 5 000 international units IU the current gold standard ACT guided heparinization results in higher doses of heparin during operation and this should not result in significantly more bleeding complications of importance
The ACTION-1 study will evaluate the effect of weight dosed heparinization during open abdominal aortic aneurysm surgeryThe study will be an international multi-centre single blind randomized controlled trial Patients will be randomized using a computerized program CASTOR EDC with a random block size of a maximum of 8 The randomization will be stratified by participating centre Separate evaluation of results and if complications can be labelled as TEC will be performed by an Independent Central Adjudication Committee The 3 members of this Committee will be blinded with regard to if the patient was randomized for ACT guided heparinization or standard bolus of 5 000 IU without ACT measurements
In the intervention group heparin is given to reach an ACT of 200-220 seconds Based on the ACT an additional dose of heparin will be administered Five minutes after every administration of heparin the ACT is measured If the ACT is 200 seconds or longer the next ACT measurement is performed every 30 minutes until the end of the procedure or until new heparin administration is required because of ACT 200 seconds Depending on the ACT value near the end of surgery protamine will be given to neutralize the effect of heparin
In the comparative group a single dose of 5 000 IU of heparin will be given 3-5 minutes before clamping of the aorta No ACT measurements will be performed except for one ACT measurement after re-establishing blood flow and removing all clamps Depending on that ACT value near the end of surgery the local protamine can be given to neutralize the effect of heparin
Heparin has an unpredictable effect in the individual patient The effect of heparin can be measured by using the Activated Clotting Time ACT ACT measurement in open AAA repair could be introduced to ensure the individual patient of safe tailor-made anticoagulation with a goal ACT of 200-220 seconds A randomized controlled trial RCT has to prove that ACT guided heparinization would result in fewer TEC and lower mortality than a standardized bolus of heparin of 5 000 international units IU the current gold standard ACT guided heparinization results in higher doses of heparin during operation and this should not result in significantly more bleeding complications of importance
The ACTION-1 study will evaluate the effect of weight dosed heparinization during open abdominal aortic aneurysm surgeryThe study will be an international multi-centre single blind randomized controlled trial Patients will be randomized using a computerized program CASTOR EDC with a random block size of a maximum of 8 The randomization will be stratified by participating centre Separate evaluation of results and if complications can be labelled as TEC will be performed by an Independent Central Adjudication Committee The 3 members of this Committee will be blinded with regard to if the patient was randomized for ACT guided heparinization or standard bolus of 5 000 IU without ACT measurements
In the intervention group heparin is given to reach an ACT of 200-220 seconds Based on the ACT an additional dose of heparin will be administered Five minutes after every administration of heparin the ACT is measured If the ACT is 200 seconds or longer the next ACT measurement is performed every 30 minutes until the end of the procedure or until new heparin administration is required because of ACT 200 seconds Depending on the ACT value near the end of surgery protamine will be given to neutralize the effect of heparin
In the comparative group a single dose of 5 000 IU of heparin will be given 3-5 minutes before clamping of the aorta No ACT measurements will be performed except for one ACT measurement after re-establishing blood flow and removing all clamps Depending on that ACT value near the end of surgery the local protamine can be given to neutralize the effect of heparin
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