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

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

Sponsors

Lead sponsor: Yonsei University

Source 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.

Overall Status Recruiting
Start Date February 6, 2020
Completion Date December 2021
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM) 10 minutes after induction of anesthesia
Maximal Clot firmness (MCF) of EXTEM 1 minutes after rewarming (during CPB)
Maximal Clot firmness (MCF) of EXTEM 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Secondary Outcome
Measure Time Frame
Clotting Time (CT) 10 minutes after induction of anesthesia
Clotting Time (CT) 1 minutes after rewarming (during CPB)
Clotting Time (CT) 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Clot Formation Time (CFT) 10 minutes after induction of anesthesia
Clot Formation Time (CFT) 1 minutes after rewarming (during CPB)
Clot Formation Time (CFT) 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
A10 10 minutes after induction of anesthesia
A10 1 minutes after rewarming (during CPB)
A10 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Maximal Clot firmness (MCF) 10 minutes after induction of anesthesia
Maximal Clot firmness (MCF) 1 minutes after rewarming (during CPB)
Maximal Clot firmness (MCF) 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. postoperative 48 hours for plasma product transfusion
Enrollment 104
Condition
Intervention

Intervention type: Procedure

Intervention name: Conventional crystalloid solution-based priming

Description: 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).

Arm group label: control

Intervention type: Procedure

Intervention name: Retrograde autologous priming

Description: 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.

Arm group label: RAP

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)

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Jong Wook Song

Phone: +82 2 2224 3971

Email: [email protected]

Location
facility status contact Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine Jong Wook Song +82-2-2224-3971 [email protected]
Location Countries

Korea, Republic of

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: control

Arm group type: Active Comparator

Description: Conventional crystalloid solution-based priming

Arm group label: RAP

Arm group type: Experimental

Description: Retrograde autologous priming

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Double (Participant, 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.

Source: ClinicalTrials.gov