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Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

NCT ID: NCT02513862

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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C.Surgical Procedure; Cardiac

Keywords

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autologous platelet rich plasma deep hypothermic circulatory arrest transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous Platelet-Rich Plasma Harvest Technique

Intervention Type DEVICE

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).

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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neutralizing heparin with protamine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hongwen Ji

OTHER

Sponsor Role lead

Responsible Party

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Hongwen Ji

professor of medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hongwen Ji, MD

Role: STUDY_CHAIR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Yongyuan Wang

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Locations

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Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2014-zx011

Identifier Type: -

Identifier Source: org_study_id