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Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery

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Yonsei University

Status

Completed

Conditions

Cardiac Surgery
Vascular Surgery Using CPB

Treatments

Procedure: Retrograde autologous priming
Procedure: Conventional crystalloid solution-based priming

Study type

Interventional

Funder types

Other

Identifiers

NCT04239677
4-2019-1088

Details and patient eligibility

About

Cardiac surgery with cardiopulmonary bypass (CPB) is associated with an increased risk of blood transfusions. The primary setup of the CPB circuit demands a priming volume of approximately 1600 mL of crystalloid solution which leads to a relevant hemodilution. The retrograde autologous priming (RAP) procedure minimizes hemodilution by displacing the crystalloid priming volume of arterial and venous lines via passive exsanguination of native blood prior to CPB initiation, resulting in higher hematocrits and reduction of red blood cell transfusion. RAP can also minimize the dilution of coagulation factors as well as red blood cells. Thus, the investigators hypothesized that RAP could maintain better coagulatory function after CPB. In this study, the investigators investigate the impact of RAP on the coagulation profile assessed by rotation thromboelastometry (ROTEM) in participants undergoing cardiac surgery.

Enrollment

104 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB

Exclusion criteria

  • Emergency operation
  • Hemoglobin concentration above 15g/dL
  • Anticoagulants such as warfarin within 5 days before surgery, non-vitamin K antagonist oral
  • anticoagulant within 2 days, and aspirin / clopidogrel / ticagrelor within 5 days
  • Weight less than 45kg, more than 90kg
  • Patients with autoimmune disease
  • Patients who participated in other clinical studies that could affect prognosis
  • Patients who cannot understand the informed consent (eg. Foreigner)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

control
Active Comparator group
Description:
Conventional crystalloid solution-based priming
Treatment:
Procedure: Conventional crystalloid solution-based priming
RAP
Experimental group
Description:
Retrograde autologous priming
Treatment:
Procedure: Retrograde autologous priming

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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