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

Not Applicable

Completed

• Conditions: Vascular Surgery Using CPB; Cardiac Surgery
• Interventions: Procedure: Conventional crystalloid solution-based priming; Procedure: Retrograde autologous priming

• Registration Number: NCT04239677
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Study Start: 2020-02-06
• Status Verified: 2021-09
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Conventional crystalloid solution-based priming	Conventional crystalloid solution-based priming
RAP	Retrograde autologous priming	Retrograde autologous priming

Primary Outcome Measures

Name	Time	Method
Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)	10 minutes after induction of anesthesia	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.
Maximal Clot firmness (MCF) of EXTEM	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)	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.

Secondary Outcome Measures

Name	Time	Method
the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.	postoperative 48 hours for plasma product transfusion	plasma product transfusion - the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.
Clotting Time (CT)	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)	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.
Clot Formation Time (CFT)	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)	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.
A10	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)	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.
Maximal Clot firmness (MCF)	15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)	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.

Trial Locations

Locations (1)

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