Surgery Clinical Trial
— ACTION-1Official title:
ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial.
Verified date | February 2024 |
Source | Dijklander Ziekenhuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 750 |
Est. completion date | November 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Krankenhaus Barmherzige Brüder | Regensburg | |
Netherlands | Ziekenhuisgroep Twente | Almelo | |
Netherlands | AUMC Location AMC | Amsterdam | Noord Holland |
Netherlands | AUMC Location VUmc | Amsterdam | Noord Holland |
Netherlands | Gelre Ziekenhuizen | Apeldoorn | Gelderland |
Netherlands | Rijnstate | Arnhem | Gelderland |
Netherlands | Amphia | Breda | Noord-Brabant |
Netherlands | Haaglanden Medisch Centrum | Den Haag | Zuid-Holland |
Netherlands | Slingeland Ziekenhuis | Doetinchem | Gelderland |
Netherlands | Catharina Ziekenhuis | Eindhoven | Noord-Brabant |
Netherlands | Treant Zorggroep | Emmen | Drenthe |
Netherlands | Medisch Spectrum Twente | Enschede | Overijssel |
Netherlands | Groene Hart | Gouda | Zuid-Holland |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Netherlands | Dijklander Ziekenhuis | Hoorn | Noord-Holland |
Netherlands | Leiden Universitair Medisch Centrum | Leiden | Zuid-Holland |
Netherlands | Alrijne | Leiderdorp | Zuid-Holland |
Netherlands | St. Antonius ziekenhuis | Nieuwegein | |
Netherlands | Maasstad Ziekenhuis | Rotterdam | Zuid-Holland |
Netherlands | Elisabeth TweeSteden Ziekenhuis | Tilburg | Noord-Braband |
Netherlands | Isala | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Dijklander Ziekenhuis | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, ZonMw: The Netherlands Organisation for Health Research and Development |
Germany, Netherlands,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality. | TEC are any complication as caused by thrombus or embolus perioperatively, including but not exclusively: myocardial infarction, leg ischemia, deep venous thrombosis, colon ischemia, transient ischemic attack (TIA)/stroke, graft thrombosis, peroperative thrombus requiring embolectomy or redo of an anastomosis, thrombus or embolus in organs or lower limbs and other peripheral thrombosis. Incidence of bleeding complications according to European multicenter study on Coronary Artery Bypass Grafting (E-CABG) classification, grade 1 and higher: per- or postoperative transfusion of 2 or more units of red blood cells, transfusion of platelets, transfusion of fresh frozen plasma or reoperation for bleeding during hospital stay. | Within 30 days or during the same admission in hospital | |
Secondary | Complications (non-TEC). | All complications requiring re-operation, longer hospital stay, all other complications. Incidence of kidney injury as defined by RIFLE criteria: rise of serum creatinine > 100% or decrease of estimated Glomerular Filtration Rate (eGFR) with 50%.32 Allergic reactions. ACT values (in intervention group), total heparin administration, protamine administration. Peroperative blood loss, blood transfusions either autologous or homologous, other blood products administration, total operative time, aortic clamping time, use of adjunctive haemostatic products, length of hospital (including ICU) stay. Health status as measured with the EQ-5D-5L. Economic and healthcare costs evaluation by the institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire(IMCQ) and iMTA Productivity Cost Questionnaire (IPCQ) and addition of out-of-pocket expenses. | Within 30 days or during the same admission in hospital |
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