NCT03426293|Completed
Measuring the ACT During Non-cardiac Arterial Procedures.
MANCO
MANCO: Measuring the ACT During Non-cardiac Arterial Procedures.
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MANCO
MANCO: Measuring the ACT During Non-cardiac Arterial Procedures.
Sponsor study identifier
observational
1,000
1 country
3
Study Start
December 21, 2016
Actual (reported)Primary Completion
January 31, 2024
Actual (reported)Study Completion
January 31, 2024
Actual (reported)Aim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during NCVI (Non-Cardiac Vascular Interventions) is essential to ensure the individual patient of safe and tailor-made anticoagulation. Not measuring the effect of the administered heparin exposes the patient to unnecessary risks of thrombo-embolic and bleeding complications. First aim of the MANCO study is to prove that the standardized bolus of 5000 IU of heparin, used by 90% of vascular specialists in Europe, results in inadequate anticoagulation in more than 80% of patients. These measurements will be performed using the Hemostasis Management System by Medtronic.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2016
Actual (reported)January 27, 2018
Actual (reported)February 8, 2018
Actual (reported)January 31, 2024
Actual (reported)January 31, 2024
Actual (reported)Change of Activated Clotting Time
Change of Activated Clotting Time, before and after administration of heparin
ACT measured before heparin, 5 minutes after and than at 30 minutes intervals. After a repeated dose of heparin again after 5 minutes and 30 minutes intervals
Complications
30 days or same admission, 6 weeks, 6 months and 12 months
All patients undergoing an open or endovascular arterial procedure in which heparin is used peri-procedurally and the ACT is measured to determine effect of heparin
Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
\- All patients in participating centers undergoing NCVI, older than 18 years
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, 1081HV, Netherlands
Westfriesgasthuis
Hoorn, North Holland, 1624NP, Netherlands
Isala klinieken
Zwolle, 8025 AB, Netherlands
Wiersema AM, Watts C, Durran AC, Reijnen MM, van Delden OM, Moll FL, Vos JA. The Use of Heparin during Endovascular Peripheral Arterial Interventions: A Synopsis. Scientifica (Cairo). 2016;2016:1456298. doi: 10.1155/2016/1456298. Epub 2016 Apr 17.
Wiersema A, Jongkind V, Bruijninckx C, Reijnen M, Vos J, Van Delden O, Zeebregts C, Moll F. Prophylactic intraoperative antithrombotics in open infrainguinal arterial bypass surgery: a systematic review. J Cardiovasc Surg (Torino). 2015 Feb;56(1):127-43. Epub 2014 Mar 4.
Arno M Wiersema, MD, PhD
Dijklander Ziekenhuis
1,000 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2018
First Posted
February 8, 2018
Study Start
December 21, 2016
Actual (reported)Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry
Contact the study team to confirm eligibility.
Wiersema AM, Vos JA, Bruijninckx CMA, van Delden OM, Reijnen MMPJ, Vahl A, Zeebregts CJ, Moll FL. Periprocedural prophylactic antithrombotic strategies in interventional radiology: current practice in the Netherlands and comparison with the United kingdom. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1477-1492. doi: 10.1007/s00270-013-0558-6. Epub 2013 Feb 13.
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.
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.
Mabry CD, Thompson BW, Read RC. Activated clotting time (ACT) monitoring of intraoperative heparinization in peripheral vascular surgery. Am J Surg. 1979 Dec;138(6):894-900. doi: 10.1016/0002-9610(79)90318-0.
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.
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.
Primary Completion
January 31, 2024
Actual (reported)Study Completion
January 31, 2024
Actual (reported)Last Updated
February 6, 2025
Record last verified: 2025-02
All ACT values can be obtained after trial with PI
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Source: ClinicalTrials.gov.
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