Measuring the ACT During Non-cardiac Arterial Procedures.

NCT03426293 | Completed

• 1 other identifier: M016-045
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Arterial Disease; Surgery; PTA; Peripheral Arterial Disease

Keywords

heparin;ACT;non-cardiac vascular;peri-procedural

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Complications

  30 days or same admission, 6 weeks, 6 months and 12 months

Study Arms (1)

Arterial procedure and ACT measurement

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

Other: Measuring the ACT to determine effect of heparin

Interventions

Measuring the ACT to determine effect of heparin OTHER

Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures

Arterial procedure and ACT measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- All patients in participating centers undergoing NCVI, older than 18 years

You may qualify if:

• All patients in participating centers undergoing Non-Cardiac Vascular (arterial) Intervention open or endovascular, older than 18 years

You may not qualify if:

• Patients with a known history of coagulation disorders or a EGFR lower than 30 ml/min.

Sponsors & Collaborators

• Dijklander Ziekenhuis: lead
• Medtronic: collaborator

Study Sites (3)

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1081HV, Netherlands

Location

Westfriesgasthuis

Hoorn, North Holland, 1624NP, Netherlands

Location

Isala klinieken

Zwolle, 8025 AB, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 27190678 BACKGROUND

• 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.

  PMID: 24594802 BACKGROUND

• 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.

  PMID: 23404518 BACKGROUND

• 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.

  PMID: 22831869 BACKGROUND

• 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.

  PMID: 23408671 BACKGROUND

• 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.

  PMID: 507308 BACKGROUND

• 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.

  PMID: 28943189 BACKGROUND

• 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.

  PMID: 28802634 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Arno M Wiersema, MD, PhD

  Dijklander Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 8, 2018
• Study Start: December 21, 2016
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after completion
• Access Criteria: mail PI

Locations

NL (3)