Clinical trial NCT04239677: Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
Official title: Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Vascular Surgery Using CPB
Keywords: retrograde autologous priming
ROTEM
Cardiac surgery
Vasculsr surgery using CPB
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)
timeFrame: 10 minutes after induction of anesthesia
measure: Maximal Clot firmness (MCF) of EXTEM
timeFrame: 1 minutes after rewarming (during CPB)
measure: Maximal Clot firmness (MCF) of EXTEM
timeFrame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Secondary outcomes:
measure: Clotting Time (CT)
timeFrame: 10 minutes after induction of anesthesia
measure: Clotting Time (CT)
timeFrame: 1 minutes after rewarming (during CPB)
measure: Clotting Time (CT)
timeFrame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
measure: Clot Formation Time (CFT)
timeFrame: 10 minutes after induction of anesthesia
measure: Clot Formation Time (CFT)
timeFrame: 1 minutes after rewarming (during CPB)
measure: Clot Formation Time (CFT)
timeFrame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
measure: A10
timeFrame: 10 minutes after induction of anesthesia
measure: A10
timeFrame: 1 minutes after rewarming (during CPB)
measure: A10
timeFrame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
measure: Maximal Clot firmness (MCF)
timeFrame: 10 minutes after induction of anesthesia
measure: Maximal Clot firmness (MCF)
timeFrame: 1 minutes after rewarming (during CPB)
measure: Maximal Clot firmness (MCF)
timeFrame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
measure: the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.
timeFrame: postoperative 48 hours for plasma product transfusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine
Study officials:
References: