ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair. (ACTION-1)
Abdominal Aortic Aneurysm, Surgery, Arterial Disease
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring ACT guided heparinization in open aortic surgery
Eligibility Criteria
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
Sites / Locations
- Universitätsklinikum Hamburg-EppendorfRecruiting
- Krankenhaus Barmherzige BrüderRecruiting
- Treant ZorggroepRecruiting
- Gelre ZiekenhuizenRecruiting
- RijnstateRecruiting
- Slingeland ZiekenhuisRecruiting
- AUMC Location VUmc
- AUMC Location AMCRecruiting
- Elisabeth TweeSteden ZiekenhuisRecruiting
- Amphia
- Catharina ZiekenhuisRecruiting
- Dijklander ZiekenhuisRecruiting
- Medisch Spectrum TwenteRecruiting
- IsalaRecruiting
- Haaglanden Medisch Centrum
- Groene HartRecruiting
- Leiden Universitair Medisch CentrumRecruiting
- AlrijneRecruiting
- Maasstad Ziekenhuis
- Ziekenhuisgroep TwenteRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- St. Antonius ziekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ACT guided heparinization
5 000 IU of heparin
Heparin is given to reach an ACT of 200-220 seconds. At the start of the procedure, before any heparin is given, a baseline ACT measurement is performed. 3-5 minutes before clamping of the aorta 100 IU/kg bodyweight of heparin is administrated intravenously. 5 minutes after administration of heparin, ACT measurement is performed.
A single dose of 5 000 IU of heparin is given 3-5 minutes before clamping of the aorta. No ACT measurements are 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. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.