Skip to content

An observational study of heparin administration and reversal during catheter ablation for atrial fibrillation (CA-AF).

A Heuristic Approach to determine the optimal method of Heparin Dosing and Reversal in all Patients Undergoing Anaesthesia for Catheter Ablation for Atrial Fibrillation (CA-AF)'

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001489280
Acronym
Heparin Heuristics
Enrollment
710
Registered
2018-09-05
Start date
2009-03-09
Completion date
2020-07-30
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

:This study was initiated to clarify the confusing response to heparin and the difficulty in obtaining adequate heparinisation during catheter ablation for atrial fibrillation (CA-AF). The initial pilot study enabled a more rational approach to heparin management, and after recruiting 500 patients into the study, analysis is progressing with a view to demonstrating a method that enables: o accurate prediction of the heparin dose required to achieve an ACT with the desired range o maintenance of the ACT within the desired range during the procedure o a simple method for reversing the active heparin with protamine.

Interventions

Each patient serves as their own control for the purpose of observing intravenous protamine dosage. The patients are grouped according to the type of point of care ACT measuring device, and the oral anticoagulant they are taking. Each patient will be compared only to the median value of the slope of the heparin dose-response curve, as indicated below. The data has been collected during the Course of routine anaesthesia for patients, starting in 2009. Pre heparin ACT was added to the data collect

Each patient serves as their own control for the purpose of observing intravenous protamine dosage. The patients are grouped according to the type of point of care ACT measuring device, and the oral anticoagulant they are taking. Each patient will be compared only to the median value of the slope of the heparin dose-response curve, as indicated below. The data has been collected during the Course of routine anaesthesia for patients, starting in 2009. Pre heparin ACT was added to the data collected in 2011. Heparin and protamine are administered intravenously as part of standard procedure. Heparin is required because the cardiologist inserts catheters into the right and left atria, and there is a significant risk of embolism and stroke in the presence of atrial fibrillation during the procedure. Each patient undergoing CA-AF is given an intravenous dose of heparin to achieve an ACT of between 300 and 400 seconds. As each patient responds to heparin in a different manner, each patient requires the dose to be individualised. Thereafter, a heparin infusion is started between 0.2 and 0.3 times the initial heparin dose per hour, and adjusted by administration or a bolus dose of heparin or altering the infusion rate to maintain the desired ACT. Between three and four hours after the start of the procedure, when the procedure is completed, a dose of protamine is administered intravenously to reverse the heparin and achieve an ACT similar to the ACT before the initial dose of heparin. For purposes of the study, the patient is observed for the duration of anaesthesia. Information recorded for the study forms part of the normal anaesthetic record and would be recorded even if the study were not to take place. The approximate dose of protamine for reversal of heparin is 1 mG for every 1 mG (100 International Units) of heparin given to achieve the desired ACT. The initial dose of heparin and the resultant ACT enables the slope the heparin dose (mg/Kg) or heparin concentration (units/mL) to be calculated. It is hoped that by calculating the median values over a large number of observations, that a mathematical model can be derived that would allow the median slope to be used to calculate a predictable dose of heparin for each individual patient to achieve the desired ACT. Once the individual heparin dose-response curve has been developed, subsequent doses of heparin can be calculated to maintain the ACT. Additionally, the pre-protamine ACT can be used in conjunction with the slope to calculate the approximate amount of active heparin, and hence the appropriate dose of protamine to reverse that heparin.

Sponsors

Philip Cumpston
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients presenting for catheter ablation for atrial fibrillation, or implantation of a left atrial occlusion device.

Exclusion criteria

Known allergic response to heparin. In this case, heparin will not be used. Known history of heparin induced thrombosis/thrombocytopenia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026