ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial.

Phase 4

Completed

Conditions: 10002363
abdominal aortic aneurysm
dilated bloodvessel in abdomen

Registration Number: NL-OMON55676

Lead Sponsor: Dijklander Ziekenhuis

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 279

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 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 (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 fish protein or protamine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints: Combined incidence of all thrombo-embolic complications<br /><br>(TEC) and all-cause mortality within<br /><br>30 days or during the same admission in hospital. TEC are any complication as<br /><br>caused by thrombus or embolus perioperatively, including but not exclusively:<br /><br>myocardial infarction, leg ischemia, deep venous thrombosis, colon ischemia,<br /><br>TIA/stroke, graft thrombosis, peroperative thrombus requiring embolectomy or<br /><br>redo of an anastomosis, thrombus or embolus in organs or lower limbs and other<br /><br>peripheral thrombosis. Incidence of bleeding complications according to E-CABG<br /><br>classification, grade 1 and higher: per- or postoperative transfusion of 2 or<br /><br>more units of red blood cells, transfusion of platelets, transfusion of fresh<br /><br>frozen plasma or reoperation for bleeding during hospital stay.</p><br>

Secondary Outcome Measures