Region 5 is now enrolling thoracic organ donors into its Mild Hypothermia Randomized Controlled Trial.
Based on feedback from thoracic transplant physicians, the following standard operating procedures for thoracic cases will be used:
Donors will not be cooled until it is confirmed that the hospital can provide:
- A warming blanket which will be set at 36.6 to 37.2 Celcius and placed under the donor in the OR
- A Bair hugger which will be set to the highest temperature and placed on the lower body
- A warm blanket or Bair hugger which will be placed over the head
- Internal cardiac paddles available, tested and staff are familiar with use
In the OR:
- The temperature will be kept above 34 degrees Celsius
- Temperature will be documented every thirty minutes
- Any incidents of arrhythmias will be tracked
- Thoracic teams may consider not doing IVC maneuvers until heparin has been given due to potential atrial arrhythmias
- Anesthesia and surgical teams will be will be aware and ready to meet these targets
Clinical Trial Background
The goal was to demonstrate that mild hypothermia (34-35°C) in the DNDD for approximately 12 hours before organ recovery will protect the allograft during the transplant process. See original post from March 5, 2012.
At the December 2012 Region 5 business meeting, the region’s research committee announced that the workgroup is expanding the current study to include thoracic organs.
All of the thoracic transplant programs in the OneLegacy and CTDN Donation Service Areas (DSAs) have been briefed with these data and they are comfortable accepting organs from DNDDs enrolled in the sutdy. Moving forward, the study intends to enroll all DNDDs with research authorization who meet the inclusion criteria. A summary of the study was out for public comment for three weeks and no feedback was received.
If you have questions about the study, please contact one of the following investigators:
- Claus Niemann, MD, [email protected]
- Darren Malinoski, MD, [email protected]
Or you may contact:
- Christopher Marsh, MD, [email protected] (Region 5 Research Committee Chair
- Chrystal Graybill (Regional Administrator for Reg. 5), 804-782-4631, [email protected]