No registrations found.
ID
Source
Brief title
Health condition
ACT; Heparin; Arterial; Non-cardiac vascular surgery; Hemostasis Management System
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage 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 outcome
evaluation of predictive value of HMS to reach ACT of 250 seconds by predicted dose of heparin.
All (anti)coagulation related events.
Background summary
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.
Study objective
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.
Study design
30 days after intervention or same admission; 6 weeks; 6 months; 12 months
Intervention
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.
Inclusion criteria
All patients undergoing open or endovascular arterial non-cardiac arterial surgery aged more than 18 years.
Exclusion criteria
All patients undergoing open or endovascular arterial non-cardiac arterial surgery aged younger than 18 years. Dialysis dependend or EGFR < 30 ml/min.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6788 |
NTR-old | NTR6973 |
Other | METC Noord-Holland : MO16-045 |