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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Surgery, Vascular Surgery Using CPB

Intervention / Treatment
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* Procedure: Conventional crystalloid solution-based priming
* Procedure: Retrograde autologous priming


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Conventional crystalloid solution-based priming | Procedure: Conventional crystalloid solution-based priming<br>* 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).<br>|
| Experimental: RAP<br>Retrograde autologous priming | Procedure: Retrograde autologous priming<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retrograde autologous priming, ROTEM, Cardiac surgery, Vasculsr surgery using CPB