Aim 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…
ID
Bron
Verkorte titel
Aandoening
ACT; Heparin; Arterial; Non-cardiac vascular surgery; Hemostasis Management System
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of patients reaching an ACT of 250 seconds by administering a standardized bolus of 5000 IU.<br>
Total dose of heparin needed to reach 250 seconds.
Achtergrond van het onderzoek
Aim 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.
Doel van het onderzoek
Aim 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.
Onderzoeksopzet
30 days after intervention or same admission; 6 weeks; 6 months; 12 months
Onderzoeksproduct en/of interventie
To 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients undergoing open or endovascular arterial non-cardiac arterial surgery aged more than 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
All patients undergoing open or endovascular arterial non-cardiac arterial surgery aged younger than 18 years. Dialysis dependend or EGFR < 30 ml/min.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6788 |
NTR-old | NTR6973 |
Ander register | METC Noord-Holland : MO16-045 |