ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dijklander Ziekenhuis; Westfriesgasthuis
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); AIDS Malignancy Consortium; VU University Medical Center; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Calcium heparin; Heparin; Protamines

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