PERFUSION REPORTS

REPORT

095

DATE

1/1/2022

TITLE

Protamine Administration

DETAILS OF INCIDENT

Current guideline and SOP from institution who filed report: "STOP suction pumps when A MAXIMUM of one third of protamine has been given (ideally as soon as the protamine has started). This information should be provided by the Anaesthetist. Only cell salvage suction should be utilised by this point".

Following cardiopulmonary bypass and arterial decannulation, excessive blood volumes were collected from the pump suction after the protamine administration had been initiated. Prior to a "one-third" administration point, and whist bagging off pump blood for re-transfusion, it was noticed that the reservoir volume had clotted.

DETAILS OF INJURY TO PATIENT

No related adverse outcomes to the patient.

TYPE OF DEVICE/MANUFACTURER

N/A

ACTION TAKEN

CPB circuit was replaced with the standby primed circuit, ready for re-commencement of CPB if required! Haemostasis was obtained with no related adverse outcomes to the patient.

A proposal was made to make an amendment to the clinical practice and the SOP statement to be amended as follows:

"STOP suction pumps on INITIATION of protamine test dose. This information should be clearly communicated by the Anaesthetist to both Perfusionist and Surgeon. Only cell salvage suction should be utilised from this point".

Challenges: Initially, there was resistance from the Surgeons as this clinical practice had been in place for many years without incident. Associated adverse outcome literature was also scarce. However, the anecdotal potential for protamine to jeopardise circuit integrity and in the interests of patient safety the SOP proposal was approved.

RESPONSE FROM MANUFACTURER

N/A

ADDTIONAL INFORMATION

Literature Findings:

A recent study (to be published in The Annals of Thoracic Surgery, 2021) has demonstrated an average drop of 40+/- 25% from the last ACT following the protamine test dose (p<0.0001), which in practical terms means the ACT fell below their institutional protocol for safe initiation of CPB in 81+/-5% of patients. For reference use link:

https://www.annalsthoracicsurgery.org/article/S0003-4975(21)00826-2/fulltext

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Clotted Reservoir Picture