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Meten van de geactiveerde stollingstijd tijdens slagaderlijke vaatingrepen.


- candidate number28474
- NTR NumberNTR6973
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2018
- Secondary IDsMO16-045 METC Noord-Holland
- Public TitleMeten van de geactiveerde stollingstijd tijdens slagaderlijke vaatingrepen.
- Scientific TitleMeasuring the ACT during Non-Cardiac arterial procedures.
- ACRONYMMANCO
- hypothesisAim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during NCVI 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„µ. The calculated heparin dose using the HMS will ensure every patient of tailor-made anticoagulation, thereby reducing the avoidable risks of thrombo-embolic and bleeding complications.
- Healt Condition(s) or Problem(s) studiedHeparin, Hemostasis, Activated clotting time (ACT), Non-cardiac vascular surgery
- Inclusion criteriaAll patients undergoing open or endovascular arterial non-cardiac arterial surgery aged more than 18 years.
- Exclusion criteriaAll patients undergoing open or endovascular arterial non-cardiac arterial surgery aged younger than 18 years. Dialysis dependend or EGFR < 30 ml/min.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2016
- planned closingdate1-dec-2019
- Target number of participants500
- InterventionsTo evaluate if the current practice of using a standardized bolus of 5000 IU of heparin during NCVI causes adequate periprocedural anticoagulation in the individual patient. This evaluation will be performed using the HMS. The calculated heparin dose response curve will be evaluated on the desired value of the ACT of 250 seconds. All participating centers and vascular surgeons and/or IR are allowed to apply their local heparin protocols.
- Primary outcomePercentage of patients reaching an ACT of 250 seconds by administering a standardized bolus of 5000 IU.
Total dose of heparin needed to reach 250 seconds.
- Secondary outcomeevaluation of predictive value of HMS to reach ACT of 250 seconds by predicted dose of heparin.
All (anti)coagulation related events.
- Timepoints30 days after intervention or same admission; 6 weeks; 6 months; 12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. Arno M. Wiersema
- CONTACT for SCIENTIFIC QUERIESdr. Arno M. Wiersema
- Sponsor/Initiator dr. Arno M. Wiersema, Westfriesgasthuis
- Funding
(Source(s) of Monetary or Material Support)
Medtronic
- Publications
- Brief summaryAim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during 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 ACT less than 250 seconds). These measurements will be performed using the Hemostasis Management System by Medtronic. The calculated heparin dose using the HMS will be evaluated to test its predictive value to ensure every patient of tailor-made anticoagulation, thereby reducing the avoidable risks of thrombo-embolic and bleeding complications.
- Main changes (audit trail)
- RECORD21-jan-2018 - 2-feb-2018


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