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

Yonsei University104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

104

Conditions

Cardiac Surgery Vascular Surgery Using CPB

Interventions

Conventional crystalloid solution-based primingPROCEDURE

CPB circuit is also prepared with crystalloid solution-based priming in all participants (same as the RAP group). In this group (control group), CPB is initiated with antegrade priming (conventional priming).

Retrograde autologous primingPROCEDURE

CPB circuit is prepared with crystalloid solution-based priming in all participants. In RAP group, retrograde autologous priming is performed by displacing the crystalloid priming volume of arterial and venous lines via passive exsanguination of native blood prior to CPB initiation.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)

Maximal Clot firmness (MCF) of EXTEM is a ROTEM parameter representing the strength of a clot, the formation of which is triggered by an activator of extrinsic coagulation pathway.

Time frame: 10 minutes after induction of anesthesia

Maximal Clot firmness (MCF) of EXTEM

Maximal Clot firmness (MCF) of EXTEM is a ROTEM parameter representing the strength of a clot, the formation of which is triggered by an activator of extrinsic coagulation pathway.

Time frame: 1 minutes after rewarming (during CPB)

Maximal Clot firmness (MCF) of EXTEM

Maximal Clot firmness (MCF) of EXTEM is a ROTEM parameter representing the strength of a clot, the formation of which is triggered by an activator of extrinsic coagulation pathway. Dosage of heparin and protamine is only affected by patients' real body weight (not by ROTEM results). That is, in each case, the same protamine dosage applies to both groups.

Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)