Surgery Clinical Trial
— MANCOOfficial title:
MANCO: Measuring the ACT During Non-cardiac Arterial Procedures.
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 21, 2025 |
Est. primary completion date | December 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients in participating centers undergoing Non-Cardiac Vascular (arterial) Intervention open or endovascular, older than 18 years Exclusion Criteria: - Patients with a known history of coagulation disorders or a EGFR lower than 30 ml/min. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Vrije Universiteit Medisch Centrum | Amsterdam | Noord-Holland |
Netherlands | Westfriesgasthuis | Hoorn | Noord-Holland |
Netherlands | Isala klinieken | Zwolle |
Lead Sponsor | Collaborator |
---|---|
Dijklander Ziekenhuis | Medtronic |
Netherlands,
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. — View 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. — View Citation
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. — View 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. — View Citation
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. — View 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complications | All complications as depicted in Suggested Standards for reports on arterial procedures and local complication registration. Vascular and non-vascular | 30 days or same admission, 6 weeks, 6 months and 12 months |
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