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ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair. (ACTION-1)

Primary Purpose

Abdominal Aortic Aneurysm, Surgery, Arterial Disease

Status

Recruiting

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

ACT guided heparinization

5 000 IU of heparin

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring ACT guided heparinization in open aortic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT guided heparinization

5 000 IU of heparin

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04061798

First Posted

August 18, 2019

Last Updated

December 5, 2022

Sponsor

Dijklander Ziekenhuis

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

1. Study Identification

Unique Protocol Identification Number

NCT04061798

Brief Title

ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

Acronym

ACTION-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dijklander Ziekenhuis

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm, Surgery, Arterial Disease

Keywords

ACT guided heparinization in open aortic surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Intervention group: 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.

Masking

Participant

Masking Description

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. The participant is blinded to the allocated treatment. 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.

Allocation

Randomized

Enrollment

750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ACT guided heparinization

Arm Type

Experimental

Arm Description

Arm Title

5 000 IU of heparin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ACT guided heparinization

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

5 000 IU of heparin

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Within 30 days or during the same admission in hospital

Secondary Outcome Measure Information:

Title

Complications (non-TEC).

Description

Time Frame

Within 30 days or during the same admission in hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arno M Wiersema, MD, PhD

Phone

0031653444515

arno@wiersema.nu

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Jongkind, MD, PhD

Phone

0031229257257

v.jongkind@amsterdamumc.nl

Facility Information:

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastian Debus, MD PHD

s.debus@uke.de

Facility Name

Krankenhaus Barmherzige Brüder

City

Regensburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Steinbauer, MD PhD

Phone

+49 941 3690

markus.Steinbauer@barmherzige-regensburg.de

Facility Name

Treant Zorggroep

City

Emmen

State/Province

Drenthe

ZIP/Postal Code

7824AA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rutger J Hissink, MD

Phone

+31 88 129 2929

r.hissink@treant.nl

Facility Name

Gelre Ziekenhuizen

City

Apeldoorn

State/Province

Gelderland

ZIP/Postal Code

7334DZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hessel Buscher, MD, PhD

Phone

0031555818181

h.buscher@gelre.nl

Facility Name

Rijnstate

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6815 AD

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M PJ Rijnen, MD, PhD

Phone

003188 0053 077

mmpj.reijnen@gmail.com

Facility Name

Slingeland Ziekenhuis

City

Doetinchem

State/Province

Gelderland

ZIP/Postal Code

7009BL

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan Lemson, MD PhD

Phone

0031314329911

s.lemson@slingeland.nl

Facility Name

AUMC Location VUmc

City

Amsterdam

State/Province

Noord Holland

ZIP/Postal Code

1081 HV

Country

Netherlands

Individual Site Status

Completed

Facility Name

AUMC Location AMC

City

Amsterdam

State/Province

Noord Holland

ZIP/Postal Code

1105AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M JW Koelemay, MD, PhD

Phone

003120 566 9111

m.j.koelemaij@amc.uva.nl

Facility Name

Elisabeth TweeSteden Ziekenhuis

City

Tilburg

State/Province

Noord-Braband

ZIP/Postal Code

5022 GC

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

J. Heyligers, MD, PhD

Phone

003113 2210 000

j.heyligers@etz.nl

Facility Name

Amphia

City

Breda

State/Province

Noord-Brabant

ZIP/Postal Code

4818 CK

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

L. Van Der Laan, MD, PhD

Phone

003176 5955 000

lvanderlaan@amphia.nl

Facility Name

Catharina Ziekenhuis

City

Eindhoven

State/Province

Noord-Brabant

ZIP/Postal Code

5623 EJ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

J AW Teijink, MD, PhD

Phone

003140 2396 349

joep.teijink@catharinaziekenhuis.nl

Facility Name

Dijklander Ziekenhuis

City

Hoorn

State/Province

Noord-Holland

ZIP/Postal Code

1624NP

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arno M Wiersema, MD, PhD

Phone

0031229208206

a.wiersema@westfriesgasthuis.nl

First Name & Middle Initial & Last Name & Degree

Vincent Jongkind, MD, PhD

Phone

0031229257257

v.jongkind@amsterdamumc.nl

Facility Name

Medisch Spectrum Twente

City

Enschede

State/Province

Overijssel

ZIP/Postal Code

7512 KZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

E. Willigendael, MD, PhD

Phone

003153 4872 000

E.Willigendael@mst.nl

Facility Name

Isala

City

Zwolle

State/Province

Overijssel

ZIP/Postal Code

8025 AB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M. Pierie, MD, PhD

Phone

0003138 424 5000

m.pierie@isala.nl

Facility Name

Haaglanden Medisch Centrum

City

Den Haag

State/Province

Zuid-Holland

ZIP/Postal Code

2597AX

Country

Netherlands

Individual Site Status

Completed

Facility Name

Groene Hart

City

Gouda

State/Province

Zuid-Holland

ZIP/Postal Code

2803 HH

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

P. M. Schlejen, MD, PhD

Phone

0031182 505 050

Peter.Schlejen@ghz.nl

Facility Name

Leiden Universitair Medisch Centrum

City

Leiden

State/Province

Zuid-Holland

ZIP/Postal Code

2333 ZA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

J. Van Schaik, MD, PhD

Phone

003171 5269 111

J.van_Schaik@lumc.nl

Facility Name

Alrijne

City

Leiderdorp

State/Province

Zuid-Holland

ZIP/Postal Code

2353 GA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

R. Hoencamp, MD, PhD

Phone

003171 5828 282

rhoencamp@alrijne.nl

Facility Name

Maasstad Ziekenhuis

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3079 DZ

Country

Netherlands

Individual Site Status

Completed

Facility Name

Ziekenhuisgroep Twente

City

Almelo

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boudewijn Reichmann, MD PhD

Phone

003188 708 78 78

b.reichmann@zgt.nl

Facility Name

Universitair Medisch Centrum Groningen

City

Groningen

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clark Zeebregts, MD PhD

Phone

0031503616161

c.j.a.m.zeebregts@ucmg.nl

Facility Name

St. Antonius ziekenhuis

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rogier Kropman, MD. PhD

Phone

0031883203000

r.kropman@antoniusziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

under pre-defined conditions and contract

IPD Sharing Time Frame

after data lock, 07-2024

IPD Sharing Access Criteria

contract with pre-defined criteria according to government regulation concerning science research

Citations:

PubMed Identifier

27118618

Citation

Burgers LT, Vahl AC, Severens JL, Wiersema AM, Cuypers PW, Verhagen HJ, Redekop WK. Cost-effectiveness of Elective Endovascular Aneurysm Repair Versus Open Surgical Repair of Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):29-40. doi: 10.1016/j.ejvs.2016.03.001. Epub 2016 Apr 23.

Results Reference

background

PubMed Identifier

28780975

Citation

Behrendt CA, Sedrakyan A, Riess HC, Heidemann F, Kolbel T, Petersen J, Debus ES. Short-term and long-term results of endovascular and open repair of abdominal aortic aneurysms in Germany. J Vasc Surg. 2017 Dec;66(6):1704-1711.e3. doi: 10.1016/j.jvs.2017.04.040. Epub 2017 Aug 7.

Results Reference

background

PubMed Identifier

30037737

Citation

Behrendt CA, Riess HC, Schwaneberg T, Larena-Avellaneda A, Kolbel T, Tsilimparis N, Spanos K, Debus ES, Sedrakyan A. Incidence, Predictors, and Outcomes of Colonic Ischaemia in Abdominal Aortic Aneurysm Repair. Eur J Vasc Endovasc Surg. 2018 Oct;56(4):507-513. doi: 10.1016/j.ejvs.2018.06.010. Epub 2018 Jul 20.

Results Reference

background

PubMed Identifier

28943011

Citation

Deery SE, O'Donnell TFX, Bodewes TCF, Dalebout BA, Pothof AB, Shean KE, Darling JD, Schermerhorn ML. Early reintervention after open and endovascular abdominal aortic aneurysm repair is associated with high mortality. J Vasc Surg. 2018 Feb;67(2):433-440.e1. doi: 10.1016/j.jvs.2017.06.104. Epub 2017 Sep 21.

Results Reference

background

PubMed Identifier

28110907

Citation

Trenner M, Haller B, Storck M, Reutersberg B, Kallmayer MA, Eckstein HH. Trends in Patient Safety of Intact Abdominal Aortic Aneurysm Repair: German Registry Data on 36,594 Procedures. Eur J Vasc Endovasc Surg. 2017 May;53(5):641-647. doi: 10.1016/j.ejvs.2016.12.024. Epub 2017 Jan 19.

Results Reference

background

PubMed Identifier

28073669

Citation

Hynes CF, Endicott KM, Iranmanesh S, Amdur RL, Macsata R. Reoperation rates after open and endovascular abdominal aortic aneurysm repairs. J Vasc Surg. 2017 May;65(5):1323-1328. doi: 10.1016/j.jvs.2016.09.053. Epub 2017 Jan 7.

Results Reference

background

PubMed Identifier

15483279

Citation

Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.

Results Reference

background

PubMed Identifier

23384493

Citation

Lo RC, Bensley RP, Hamdan AD, Wyers M, Adams JE, Schermerhorn ML; Vascular Study Group of New England. Gender differences in abdominal aortic aneurysm presentation, repair, and mortality in the Vascular Study Group of New England. J Vasc Surg. 2013 May;57(5):1261-8, 1268.e1-5. doi: 10.1016/j.jvs.2012.11.039. Epub 2013 Feb 4.

Results Reference

background

PubMed Identifier

23337406

Citation

Wiersema A, Bruijninckx C, Reijnen M, Vos J, Van Delden O, Vahl A, Zeebregts C, Moll F. Perioperative prophylactic antithrombotic strategies in vascular surgery: current practice in the Netherlands. J Cardiovasc Surg (Torino). 2015 Feb;56(1):119-25. Epub 2013 Jan 22.

Results Reference

background

PubMed Identifier

22831869

Citation

Wiersema AM, Jongkind V, Bruijninckx CM, Reijnen MM, Vos JA, van Delden OM, Zeebregts CJ, Moll FL; CAPPAStudy Group Consensus on Arterial PeriProcedural Anticoagulation. Prophylactic perioperative anti-thrombotics in open and endovascular abdominal aortic aneurysm (AAA) surgery: a systematic review. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):359-67. doi: 10.1016/j.ejvs.2012.06.008. Epub 2012 Jul 24.

Results Reference

background

PubMed Identifier

15383472

Citation

Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S. doi: 10.1378/chest.126.3_suppl.188S.

Results Reference

background

PubMed Identifier

23408671

Citation

Finley A, Greenberg C. Review article: heparin sensitivity and resistance: management during cardiopulmonary bypass. Anesth Analg. 2013 Jun;116(6):1210-22. doi: 10.1213/ANE.0b013e31827e4e62. Epub 2013 Feb 13.

Results Reference

background

PubMed Identifier

22743176

Citation

Arsenault KA, Paikin JS, Hirsh J, Dale B, Whitlock RP, Teoh K, Young E, Ginsberg JS, Weitz JI, Eikelboom JW. Subtle differences in commercial heparins can have serious consequences for cardiopulmonary bypass patients: A randomized controlled trial. J Thorac Cardiovasc Surg. 2012 Oct;144(4):944-950.e3. doi: 10.1016/j.jtcvs.2012.05.065. Epub 2012 Jun 27.

Results Reference

background

PubMed Identifier

8281479

Citation

Nath FC, Muller DW, Rosenschein U, Ellis SG, Topol EJ. Heparin monitoring during coronary intervention: activated clotting time versus activated partial thromboplastin time. Can J Cardiol. 1993 Nov;9(9):797-801.

Results Reference

background

PubMed Identifier

11181470

Citation

Chew DP, Bhatt DL, Lincoff AM, Moliterno DJ, Brener SJ, Wolski KE, Topol EJ. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001 Feb 20;103(7):961-6. doi: 10.1161/01.cir.103.7.961.

Results Reference

background

PubMed Identifier

21062999

Citation

Kasapis C, Gurm HS, Chetcuti SJ, Munir K, Luciano A, Smith D, Aronow HD, Kassab EH, Knox MF, Moscucci M, Share D, Grossman PM. Defining the optimal degree of heparin anticoagulation for peripheral vascular interventions: insight from a large, regional, multicenter registry. Circ Cardiovasc Interv. 2010 Dec;3(6):593-601. doi: 10.1161/CIRCINTERVENTIONS.110.957381. Epub 2010 Nov 9.

Results Reference

background

PubMed Identifier

28802634

Citation

Veerhoek D, Groepenhoff F, van der Sluijs MGJM, de Wever JWB, Blankensteijn JD, Vonk ABA, Boer C, Vermeulen CFW. Individual Differences in Heparin Sensitivity and Their Effect on Heparin Anticoagulation During Arterial Vascular Surgery. Eur J Vasc Endovasc Surg. 2017 Oct;54(4):534-541. doi: 10.1016/j.ejvs.2017.07.006. Epub 2017 Aug 9.

Results Reference

background

PubMed Identifier

7945064

Citation

Coyne TJ, Wallace MC, Benedict C. Peri-operative anticoagulant effects of heparinization for carotid endarterectomy. Aust N Z J Surg. 1994 Oct;64(10):679-83. doi: 10.1111/j.1445-2197.1994.tb02056.x.

Results Reference

background

PubMed Identifier

10493364

Citation

Poisik A, Heyer EJ, Solomon RA, Quest DO, Adams DC, Baldasserini CM, McMahon DJ, Huang J, Kim LJ, Choudhri TF, Connolly ES. Safety and efficacy of fixed-dose heparin in carotid endarterectomy. Neurosurgery. 1999 Sep;45(3):434-41; discussion 441-2. doi: 10.1097/00006123-199909000-00003.

Results Reference

background

PubMed Identifier

15967231

Citation

de Sousa AA, Dellaretti MA, Faglioni W Jr, Carvalho GT. Monitoring of activated coagulation time in carotid endarterectomy. Surg Neurol. 2005;64 Suppl 1:S1:6-9. doi: 10.1016/j.surneu.2005.04.016.

Results Reference

background

PubMed Identifier

16728233

Citation

Saw J, Bajzer C, Casserly IP, Exaire E, Haery C, Sachar R, Lee D, Abou-Chebl A, Yadav JS. Evaluating the optimal activated clotting time during carotid artery stenting. Am J Cardiol. 2006 Jun 1;97(11):1657-60. doi: 10.1016/j.amjcard.2005.12.062. Epub 2006 Apr 19.

Results Reference

background

PubMed Identifier

28943189

Citation

Goldhammer JE, Zimmerman D. Pro: Activated Clotting Time Should Be Monitored During Heparinization For Vascular Surgery. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1494-1496. doi: 10.1053/j.jvca.2017.04.047. Epub 2017 Apr 26. No abstract available.

Results Reference

background

PubMed Identifier

29571622

Citation

Dieplinger B, Egger M, Luft C, Hinterreiter F, Pernerstorfer T, Haltmayer M, Mueller T. Comparison between activated clotting time and anti-activated factor X activity for the monitoring of unfractionated heparin therapy in patients with aortic aneurysm undergoing an endovascular procedure. J Vasc Surg. 2018 Aug;68(2):400-407. doi: 10.1016/j.jvs.2017.11.079. Epub 2018 Mar 20.

Results Reference

background

PubMed Identifier

28974132

Citation

Lee JM, Park EY, Kim KM, Won JC, Jung TK, Lee SK. Comparison of activated clotting times measured using the Hemochron Jr. Signature and Medtronic ACT Plus during cardiopulmonary bypass with acute normovolemic haemodilution. J Int Med Res. 2018 Feb;46(2):873-882. doi: 10.1177/0300060517731952. Epub 2017 Oct 4.

Results Reference

background

PubMed Identifier

19277416

Citation

Chia S, Van Cott EM, Raffel OC, Jang IK. Comparison of activated clotting times obtained using Hemochron and Medtronic analysers in patients receiving anti-thrombin therapy during cardiac catheterisation. Thromb Haemost. 2009 Mar;101(3):535-40.

Results Reference

background

PubMed Identifier

26123033

Citation

Biancari F, Ruggieri VG, Perrotti A, Svenarud P, Dalen M, Onorati F, Faggian G, Santarpino G, Maselli D, Dominici C, Nardella S, Musumeci F, Gherli R, Mariscalco G, Masala N, Rubino AS, Mignosa C, De Feo M, Della Corte A, Bancone C, Chocron S, Gatti G, Gherli T, Kinnunen EM, Juvonen T. European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications. J Cardiothorac Surg. 2015 Jun 30;10:90. doi: 10.1186/s13019-015-0292-z.

Results Reference

background

PubMed Identifier

28024656

Citation

Brascia D, Reichart D, Onorati F, Perrotti A, Ruggieri VG, Bounader K, Verhoye JP, Santarpino G, Fischlein T, Maselli D, Dominici C, Mariscalco G, Gherli R, Rubino AS, De Feo M, Bancone C, Gatti G, Santini F, Dalen M, Saccocci M, Faggian G, Tauriainen T, Kinnunen EM, Nicolini F, Gherli T, Rosato S, Biancari F. Validation of Bleeding Classifications in Coronary Artery Bypass Grafting. Am J Cardiol. 2017 Mar 1;119(5):727-733. doi: 10.1016/j.amjcard.2016.11.027. Epub 2016 Dec 3.

Results Reference

background

PubMed Identifier

24276985

Citation

Mazzalai F, Piatto G, Toniato A, Lorenzetti R, Baracchini C, Ballotta E. Using protamine can significantly reduce the incidence of bleeding complications after carotid endarterectomy without increasing the risk of ischemic cerebral events. World J Surg. 2014 May;38(5):1227-32. doi: 10.1007/s00268-013-2347-4.

Results Reference

background

PubMed Identifier

29743410

Citation

Yamamoto S, Sakakura K, Taniguchi Y, Yamamoto K, Wada H, Momomura SI, Fujita H. Safety of Reversing Anticoagulation by Protamine Following Elective Transfemoral Percutaneous Coronary Intervention in the Drug-Eluting Stent Era. Int Heart J. 2018 May 30;59(3):482-488. doi: 10.1536/ihj.17-352. Epub 2018 May 9.

Results Reference

background

PubMed Identifier

30528142

Citation

Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494.

Results Reference

background

PubMed Identifier

15312219

Citation

Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

Results Reference

background

PubMed Identifier

27325326

Citation

M Versteegh M, M Vermeulen K, M A A Evers S, de Wit GA, Prenger R, A Stolk E. Dutch Tariff for the Five-Level Version of EQ-5D. Value Health. 2016 Jun;19(4):343-52. doi: 10.1016/j.jval.2016.01.003. Epub 2016 Mar 30.

Results Reference

background

PubMed Identifier

34538275

Citation

Wiersema AM, Roosendaal LC, Koelemaij MJW, Tijssen JGP, van Dieren S, Blankensteijn JD, Debus ES, Middeldorp S, Heyligers JMM, Fokma YS, Reijnen MMPJ, Jongkind V. ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair. Trials. 2021 Sep 19;22(1):639. doi: 10.1186/s13063-021-05552-7.

Results Reference

derived

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Document aorta aneurysmata; expert rapport voor doelmatig gebruik. Ned Ver v VchenZN.

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ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

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ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair. (ACTION-1)

Abdominal Aortic Aneurysm, Surgery, Arterial Disease

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