ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.
NCT ID: NCT04061798
Last Updated: 2025-02-06
Study Results
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Basic Information
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TERMINATED
PHASE4
294 participants
INTERVENTIONAL
2020-03-02
2024-04-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
Comparative group:
A single dose of 5 000 IU of heparin is given 3-5 minutes before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps.
TREATMENT
SINGLE
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 to the allocated treatment.
Since the care provider and investigator have to do the ACT measuring, it is impossible to blind them to the allocated treatment.
Study Groups
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ACT guided heparinization
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.
ACT guided heparinization
If the ACT is \<180 sec., an additional dose of heparin of 60 IU/kg is administered. If the ACT is 180-200 sec., 30 IU/kg.
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 measurement is performed every 30 min., until the end of the procedure or until new heparin administration is required. After each new dose of heparin, an ACT measurement is performed after 5 min. and the above- described protocol of ACT measurements will be repeated. After re-establishing blood flow and removing all clamps, the ACT is measured.
If the ACT at closure is 200-250 sec., 2500 IU of protamine should be administered. If \>250 sec., 5000 IU protamine. If 180-200 sec., 1000 IU protamine. 5 min. after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 sec. If the ACT is still more than 200 sec., protamine should be administered again.
5 000 IU of heparin
A single dose of 5 000 IU of heparin is given 3-5 minutes before clamping of the aorta. No ACT measurements are 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. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.
5 000 IU of heparin
A single dose of 5 000 IU of heparin is given 3-5 min before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.
If the ACT at closure is between 200 and 250 s, 2500 IU protamine should be administered. If the ACT is higher than 250 s, 5000 IU protamine should be administered. If the ACT is between 180 and 200 s, 1000 IU protamine should be administered. Five minutes after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 s. If the ACT is still more than 200 s, protamine should be administered again.
Interventions
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ACT guided heparinization
If the ACT is \<180 sec., an additional dose of heparin of 60 IU/kg is administered. If the ACT is 180-200 sec., 30 IU/kg.
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 measurement is performed every 30 min., until the end of the procedure or until new heparin administration is required. After each new dose of heparin, an ACT measurement is performed after 5 min. and the above- described protocol of ACT measurements will be repeated. After re-establishing blood flow and removing all clamps, the ACT is measured.
If the ACT at closure is 200-250 sec., 2500 IU of protamine should be administered. If \>250 sec., 5000 IU protamine. If 180-200 sec., 1000 IU protamine. 5 min. after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 sec. If the ACT is still more than 200 sec., protamine should be administered again.
5 000 IU of heparin
A single dose of 5 000 IU of heparin is given 3-5 min before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.
If the ACT at closure is between 200 and 250 s, 2500 IU protamine should be administered. If the ACT is higher than 250 s, 5000 IU protamine should be administered. If the ACT is between 180 and 200 s, 1000 IU protamine should be administered. Five minutes after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 s. If the ACT is still more than 200 s, protamine should be administered again.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Amsterdam UMC, location VUmc
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Dijklander Ziekenhuis
OTHER
Responsible Party
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Arno Wiersema
MD, PhD, Vascular Surgeon
Locations
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Krankenhaus Barmherzige Brüder
Regensburg, , Germany
Treant Zorggroep
Emmen, Drenthe, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands
Rijnstate
Arnhem, Gelderland, Netherlands
Slingeland Ziekenhuis
Doetinchem, Gelderland, Netherlands
Elisabeth TweeSteden Ziekenhuis
Tilburg, Noord-Braband, Netherlands
Amphia
Breda, North Brabant, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
AUMC Location VUmc
Amsterdam, North Holland, Netherlands
AUMC Location AMC
Amsterdam, North Holland, Netherlands
Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Groene Hart
Gouda, South Holland, Netherlands
Leiden Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Alrijne
Leiderdorp, South Holland, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands
Haaglanden Medisch Centrum
The Hague, South Holland, Netherlands
Ziekenhuisgroep Twente
Almelo, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
St. Antonius ziekenhuis
Nieuwegein, , Netherlands
Countries
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References
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Other Identifiers
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NL-66759
Identifier Type: -
Identifier Source: org_study_id
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