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

NCT04239677 | Completed

• 1 other identifier: 4-2019-1088
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Vascular Surgery Using CPB

Keywords

retrograde autologous priming; ROTEM; Cardiac surgery; Vasculsr surgery using CPB

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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)

Study Arms (2)

control

ACTIVE COMPARATOR

Conventional crystalloid solution-based priming

Procedure: Conventional crystalloid solution-based priming

RAP

EXPERIMENTAL

Retrograde autologous priming

Procedure: Retrograde autologous priming

Interventions

Conventional crystalloid solution-based priming PROCEDURE

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).

control

Retrograde autologous priming PROCEDURE

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.

RAP

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: February 6, 2020
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

KR (1)