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Completed

NCT Number: NCT02513862

Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

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.

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Key information

Conditions

C.Surgical Procedure; Cardiac

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet-Rich Plasma Harvest Technique

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).

Other names: neutralizing heparin with protamine

Primary outcomes

  1. total perioperative allogenic transfusions of platelet and fresh frozen plasma

    Time frame: on the 7th day postoperatively

Secondary outcomes

  1. postoperative blood loss

    Time frame: on the 7th day postoperatively

  2. rate of reexploration for bleeding

    Time frame: on the 7th day postoperatively

Sponsors and collaborators

Lead sponsor

Hongwen Ji

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2015
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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