Cardiac Surgery, Vascular Surgery Using CPB
Conditions
Keywords
retrograde autologous priming, ROTEM, Cardiac surgery, Vasculsr surgery using CPB
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.
Interventions
PROCEDUREConventional 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).
PROCEDURERetrograde 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
One investigator (Anesthesiologist) conducts randomized group assignment. The day of surgery, the researcher informs to surgeon, perfusionist about patient's group assignment. But, other researcher (ROTEM test), postoperative management do not know the patient's group assignment.
Intervention model description
Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 minutes after rewarming (during CPB) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clotting Time (CT) | 10 minutes after induction of anesthesia | Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) |
| Clot Formation Time (CFT) | 10 minutes after induction of anesthesia | Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) |
| A10 | 10 minutes after induction of anesthesia | Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) |
| Maximal Clot firmness (MCF) | 10 minutes after induction of anesthesia | CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM) |
| 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. |
Countries
South Korea
Outcome results
None listed