Point-of-Care ACT Testing in the Cardiovascular Operating Room

The benefits of implementing the i-STAT system in the CVOR at Augsburg Hospital in Germany.

Fast and precise determinations of activated clotting time (ACT) are essential during cardiopulmonary bypass (CPB) surgery to monitor the degree of heparin-induced anti-coagulation. An inaccurate ACT puts patients at risk for thrombosis and hemorrhage and risks damage to the extracorporeal circuit.

This white paper describes the rationale behind the implementation of the i-STAT System at Augsburg Hospital, where mechanical ACT testing has been used for many years. Data, collected on site, are described which compare the precision of the i-STAT System to its traditional, mechanically based ACT testing device.

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Rationale for i-STAT Implementation

Goal:

Improved efficiency

Improvement

Precision on the i-STAT gave clinicians confidence in the results. Repeat testing on comparator device added an additional 17 minutes in 7% of samples.

Goal:

Reduced QC workload

Improvement

  • No testing interruption for QC testing
  • i-STAT System QC easily customisable to be compliant with the RiliBAk system
  • QC results sent directly to IT system creating a paperless documentation and verification

Goal:

IT connectivity

Compliance

Full integration into Augsburg Hospital's IT system.

Results of Data Comparison

  • Of the duplicate samples TESTED WITHIN THE THERAPEUTIC RANGE (<450 s), 15% (8) had a duplicate difference of (>50 s) WITH THE comparator, compared TO 3% (1) of i-STAT duplicates
  • In 7% of the duplicates on the comparator device, one of the duplicate measurements fell out of range (>1000 s) while the other one was in range. This did not occur on the i-STAT System 
  • The average difference between the i-STAT duplicates was 26.3 seconds, 30% better than the average difference of 37.4 seconds for the comparator device

View The Complete Case Study

Results of Data Comparison

  • Of the duplicate samples TESTED WITHIN THE THERAPEUTIC RANGE (<450 s), 15% (8) had a duplicate difference of (>50 s) WITH THE comparator, compared TO 3% (1) of i-STAT duplicates
  • In 7% of the duplicates on the comparator device, one of the duplicate measurements fell out of range (>1000 s) while the other one was in range. This did not occur on the i-STAT System 
  • The average difference between the i-STAT duplicates was 26.3 seconds, 30% better than the average difference of 37.4 seconds for the comparator device

View The Complete Case Study