Status:
TERMINATED
ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.
Lead Sponsor:
Dijklander Ziekenhuis
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC, location VUmc
Conditions:
Abdominal Aortic Aneurysm
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
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 mort...
Eligibility Criteria
Inclusion
- Able to speak and read in local language of trial hospital.
- Patients older than 18 years scheduled for elective, open repair of an iliac or abdominal aortic aneurysm distal of the Superior Mesenteric Artery (SMA) (DSAA segment C).
- Implantation of a tube or bifurcation prosthesis.
- Trans-abdominal or retroperitoneal surgical approach of aneurysm.
- Able and willing to provide written informed consent.
Exclusion
- Not able to provide written informed consent.
- Previous open or endovascular intervention on the abdominal aorta (previous surgery on other parts of the aorta or iliac arteries is not an exclusion criterion).
- History of coagulation disorders, heparin induced thrombocytopenia (HIT), allergy for heparin or thrombocyte pathology.
- Impaired renal function with EGFR below 30 ml/min.
- Acute open AAA surgery.
- Hybrid interventions.
- Connective tissue disorders.
- Dual anti-platelet therapy, which cannot be discontinued.
- Life expectancy less than 2 years.
- Inflammatory, mycotic or infected aneurysms.
- Allergy for protamine or fish protein
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04061798
Start Date
March 2 2020
End Date
April 29 2024
Last Update
February 6 2025
Active Locations (22)
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1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
2
Krankenhaus Barmherzige Brüder
Regensburg, Germany
3
Treant Zorggroep
Emmen, Drenthe, Netherlands, 7824AA
4
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands, 7334DZ