Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

Sponsor

Hongwen Ji (Other)

Overall Status

Completed

CT.gov ID

NCT02513862

Collaborator

(none)

Enrollment

Location

Arms

17.1

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
C.Surgical Procedure; Cardiac	Device: Autologous Platelet-Rich Plasma Harvest Technique	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: APRP group 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.	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). Other Names: neutralizing heparin with protamine
No Intervention: control group APRP group receive no autologous platelet-rich plasma harvest technique.

Arm

Intervention/Treatment

Experimental: APRP group

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.

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).

Other Names:

neutralizing heparin with protamine

No Intervention: control group

APRP group receive no autologous platelet-rich plasma harvest technique.

Outcome Measures

Primary Outcome Measures

total perioperative allogenic transfusions of platelet and fresh frozen plasma [on the 7th day postoperatively]

Secondary Outcome Measures

postoperative blood loss [on the 7th day postoperatively]
rate of reexploration for bleeding [on the 7th day postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing	China	100037

Sponsors and Collaborators

Hongwen Ji

Investigators

Study Chair: Hongwen Ji, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Yongyuan Wang, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC