This trial is active, not recruiting.

Condition c.surgical procedure; cardiac
Treatment autologous platelet-rich plasma harvest technique
Sponsor Hongwen Ji
Start date May 2015
End date September 2016
Trial size 80 participants
Trial identifier NCT02513862, 2014-zx011


The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
APRP group is performed autologous platelet-rich plasma harvest technique before administration of heparin to the patient,the red blood cell(RBC) component is retransfused to the patient when the RBC transfusion protocol is reached,and the autologous platelet-rich plasma is transfused to the patient immediately after heparin is neutralized with protamine.
autologous platelet-rich plasma harvest technique neutralizing heparin with protamine
15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
(No Intervention)
APRP group receive no autologous platelet-rich plasma harvest technique.

Primary Outcomes

total perioperative allogenic transfusions of platelet and fresh frozen plasma
time frame: on the 7th day postoperatively

Secondary Outcomes

postoperative blood loss
time frame: on the 7th day postoperatively
rate of reexploration for bleeding
time frame: on the 7th day postoperatively

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、 - preoperative platelet counts>150000000000/L、 - preoperative hematocrit>33%、 - without recent anticoagulants less than 5 days Exclusion Criteria: - preoperative coagulation disorder - severe renal and liver dysfunction - preoperative hemodynamic instability

Additional Information

Official title Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
Principal investigator Yongyuan Wang
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences, Fuwai Hospital.