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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239677
• Other study ID #: 4-2019-1088
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: September 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery
• Vascular Surgery Using CPB

Intervention

Procedure:
• Conventional 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).
• Retrograde 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	Clotting Time (CT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Secondary	Clotting Time (CT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Secondary	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)
Secondary	Clot Formation Time (CFT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Secondary	Clot Formation Time (CFT)	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Secondary	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)
Secondary	A10	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Secondary	A10	Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Secondary	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)
Secondary	Maximal Clot firmness (MCF)	CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	10 minutes after induction of anesthesia
Secondary	Maximal Clot firmness (MCF)	CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)	1 minutes after rewarming (during CPB)
Secondary	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)
Secondary	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