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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality.
Timeframe: Within 30 days or during the same admission in hospital