ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

ACTION-1: ACT guided heparinization during open abdominal aortic aneurysm (AAA) repair, a randomised trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22304

Enrollment

750

Registered

2020-03-02

Start date

2020-03-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Interventions

Intervention: ACT guided heparinization If the ACT is 200 sec., no extra heparin is given. 5 min. after every administration of heparin the ACT is measured. If the ACT is >200 sec, the next ACT measu

Eligibility

Inclusion 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 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

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

Design outcomes

Secondary

Measure	Time frame
Complications (non-TEC). [ Time Frame: Within 30 days or during the same admission in hospital ] 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 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 IMCQ and IPCQ and addition of out-of-pocket expenses.	—

Measure

Time frame

Complications (non-TEC). [ Time Frame: Within 30 days or during the same admission in hospital ] 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 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 IMCQ and IPCQ and addition of out-of-pocket expenses.

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Primary

Measure	Time frame
Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality. [ Time Frame: Within 30 days or during the same admission in hospital ] 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 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.	—

Measure

Time frame

Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality. [ Time Frame: Within 30 days or during the same admission in hospital ] 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 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.

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Contacts

Public ContactArno Wiersema

Dijklander ziekenhuis

arno@wiersema.nu0229-208206

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)