ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

Official Title

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

Brief 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.

Detailed Description

      Heparin is used during open abdominal aortic aneurysm (AAA) surgery to reduce thrombo-embolic
      complications (TEC): such as myocardial infarction, stroke, peripheral embolic events and the
      related mortality. On the other hand, heparin may increase blood loss, causing harm for the
      patient.

      Heparin has an unpredictable effect in the individual patient. The effect of heparin can be
      measured by using the Activated Clotting Time (ACT). ACT measurement in open AAA repair could
      be introduced to ensure the individual patient of safe, tailor-made anticoagulation with a
      goal ACT of 200-220 seconds. A randomized controlled trial (RCT) has to prove that ACT guided
      heparinization would result in fewer TEC and lower mortality than a standardized bolus of
      heparin of 5 000 international units (IU), the current gold standard. ACT guided
      heparinization results in higher doses of heparin during operation and this should not result
      in significantly more bleeding complications of importance.

      The ACTION-1 study will evaluate the effect of weight dosed heparinization during open
      abdominal aortic aneurysm surgery.The study will be an international multi-centre single
      blind randomized controlled trial. Patients will be randomized using a computerized program
      (CASTOR EDC) with a random block size of a maximum of 8. The randomization will be stratified
      by participating centre. Separate evaluation of results and if complications can be labelled
      as TEC, will be performed by an Independent Central Adjudication Committee. The 3 members of
      this Committee will be blinded with regard to if the patient was randomized for ACT guided
      heparinization or standard bolus of 5 000 IU without ACT measurements.

      In the intervention group, heparin is given to reach an ACT of 200-220 seconds. Based on the
      ACT, an additional dose of heparin will be administered. Five minutes after every
      administration of heparin the ACT is measured. If the ACT is 200 seconds or longer, the next
      ACT measurement is performed every 30 minutes, until the end of the procedure or until new
      heparin administration is required (because of ACT < 200 seconds). Depending on the ACT value
      near the end of surgery, protamine will be given to neutralize the effect of heparin.

      In the comparative group, a single dose of 5 000 IU of heparin will be given 3-5 minutes
      before clamping of the aorta. No ACT measurements will be 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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Combined incidence of all thrombo-embolic complications (TEC) and all-cause mortality.

Secondary Outcome

 Complications (non-TEC).

Condition

Abdominal Aortic Aneurysm

Intervention

ACT guided heparinization

Study Arms / Comparison Groups

 ACT guided heparinization
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

750

Start Date

March 2, 2020

Completion Date

November 2024

Primary Completion Date

January 2024

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 0031653444515, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04061798

Organization ID

NL-66759

Responsible Party

Principal Investigator

Study Sponsor

Dijklander Ziekenhuis

Collaborators

 ZonMw: The Netherlands Organisation for Health Research and Development

Study Sponsor

, ,

Verification Date

October 2021