Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

C.Surgical Procedure; Cardiac Clinical Trial

Official title:

Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513862
• Other study ID #: 2014-zx011
• Status: Completed
• Phase: N/A
• First received: June 23, 2015
• Last updated: November 15, 2016
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Intervention

Device:
• Autologous Platelet-Rich Plasma Harvest Technique
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).

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hongwen Ji

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total perioperative allogenic transfusions of platelet and fresh frozen plasma		on the 7th day postoperatively	Yes
Secondary	postoperative blood loss		on the 7th day postoperatively	Yes
Secondary	rate of reexploration for bleeding		on the 7th day postoperatively	Yes