Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

• Platelet Transfusion (Biological): All platelet transfusions will be given as 10mL/kg as is considered standard of care.

Primary outcomes

• Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery [Within the first 24 hours post-op.]: Chest tube output for first 24 hours following cardiopulmonary bypass surgery

Secondary outcomes

• Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op [During hospitalization in the first 48 hours (no follow-up visits necessary)]: Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)
• Total Platelet Volume Transfused in the First 48 Hours Post-op [During hospitalization in the first 48 hours (no follow-up visits necessary)]: Total platelet volume transfused in the first 48 hours post-op
• Total Plasma Volume Transfused in the First 48 Hours Post-op [During hospitalization in the first 48 hours (no follow-up visits necessary)]: Total plasma volume transfused in the first 48 hours post-op
• Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. [During hospitalization in the first 48 hours (no follow-up visits necessary)]: Total cryoprecipitate volume transfused in the first 48 hours post-op.

Sex: All, ages: any to 18 Years

Inclusion Criteria:

* Male or female 0 up to and including 18 years of age
* Undergoing elective cardiopulmonary bypass surgery
* Are planned to have a chest tube placed in the operating room prior to chest closure

Exclusion Criteria:

* >/=19 years of age
* Preterm infants (less than 38-week gestational age at time of surgery)
* On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
* Family requests limitation of blood products (i.e. Jehovah's Witness)
* Congenital bleeding disorder
* Are planned to require ECMO post-op
* Previously enrolled in the study

Participant flow

Outcome results

• Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery (Primary), Median, mL/kg: Pathogen-reduced (PR) Platelet Transfusions 35.3 (35.3 to 35.3); Large Volume Delayed Sampling - LVDS 21.0 (21.0 to 21.0); No Platelet Transfusion 6.6 (5.1 to 10.5)
• Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op (Secondary), Median, mL/kg: Pathogen-reduced (PR) Platelet Transfusions 18.8 (18.8 to 18.8); Large Volume Delayed Sampling - LVDS 20.3 (20.3 to 20.3); No Platelet Transfusion 4.8 (0 to 6.3)
• Total Platelet Volume Transfused in the First 48 Hours Post-op (Secondary), Median, mL/kg: Pathogen-reduced (PR) Platelet Transfusions 18.8 (18.8 to 18.8); Large Volume Delayed Sampling - LVDS 14.1 (14.1 to 14.1); No Platelet Transfusion
• Total Plasma Volume Transfused in the First 48 Hours Post-op (Secondary), Median, mL/kg: Pathogen-reduced (PR) Platelet Transfusions 18.1 (18.1 to 18.1); Large Volume Delayed Sampling - LVDS 10 (10 to 10); No Platelet Transfusion
• Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op. (Secondary), Median, mL/kg: Pathogen-reduced (PR) Platelet Transfusions 17.5 (17.5 to 17.5); Large Volume Delayed Sampling - LVDS 5.1 (5.1 to 5.1); No Platelet Transfusion

Adverse events

Time frame: Adverse events data were collected during the subjects hospital course (varied by patient but no longer than 14 days)

Limitations and caveats: Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.

• Study Protocol and Statistical Analysis Plan (PDF, 2023-12-31)

• Marianne Nellis, MD, MS, Principal investigator, Weill Medical College of Cornell University