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

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery; Vascular Surgery Using CPB
• Intervention / Treatment: Procedure: Conventional crystalloid solution-based priming; Procedure: Retrograde autologous priming

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; Conventional crystalloid solution-based priming	Procedure: Conventional crystalloid solution-based priming; 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).
Experimental: RAP; Retrograde autologous priming	Procedure: Retrograde autologous priming; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clotting Time (CT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Clotting Time (CT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Clotting Time (CT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) 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.	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Clot Formation Time (CFT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Clot Formation Time (CFT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Clot Formation Time (CFT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) 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.	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
A10	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
A10	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
A10	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) 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.	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Maximal Clot firmness (MCF)	CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Maximal Clot firmness (MCF)	CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Maximal Clot firmness (MCF)	CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) 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.	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.	plasma product transfusion - the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.	postoperative 48 hours for plasma product transfusion

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac surgery; ROTEM; retrograde autologous priming; Vasculsr surgery using CPB
• Other Study ID Numbers: 4-2019-1088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No