Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery
Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
August 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 16, 2016
November 1, 2016
1.1 years
June 23, 2015
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total perioperative allogenic transfusions of platelet and fresh frozen plasma
on the 7th day postoperatively
Secondary Outcomes (2)
postoperative blood loss
on the 7th day postoperatively
rate of reexploration for bleeding
on the 7th day postoperatively
Study Arms (2)
APRP group
EXPERIMENTALAPRP 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.
control group
NO INTERVENTIONAPRP group receive no autologous platelet-rich plasma harvest technique.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- preoperative coagulation disorder
- severe renal and liver dysfunction
- preoperative hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hongwen Jilead
Study Sites (1)
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037, China
Study Officials
- STUDY CHAIR
Hongwen Ji, MD
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
- PRINCIPAL INVESTIGATOR
Yongyuan Wang
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor of medicine
Study Record Dates
First Submitted
June 23, 2015
First Posted
August 3, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2016
Study Completion
October 1, 2016
Last Updated
November 16, 2016
Record last verified: 2016-11