Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

Study Overview
=================
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.

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

Conditions
-----------------
C.Surgical Procedure; Cardiac

Intervention / Treatment
-----------------
* Device: Autologous Platelet-Rich Plasma Harvest Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APRP group<br>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<br>* 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).<br>* Other names: neutralizing heparin with protamine;|
| No Intervention: control group<br>APRP group receive no autologous platelet-rich plasma harvest technique. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total perioperative allogenic transfusions of platelet and fresh frozen plasma |  | on the 7th day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood loss |  | on the 7th day postoperatively | 
| rate of reexploration for bleeding |  | on the 7th day postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous platelet rich plasma, deep hypothermic circulatory arrest, transfusion