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NCT Number: NCT04239677

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

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.

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Key information

Conditions

Cardiac Surgery Vascular Surgery Using CPB

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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.

Primary outcomes

  1. Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM)

    Time frame: 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.

  2. Maximal Clot firmness (MCF) of EXTEM

    Time frame: 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.

  3. Maximal Clot firmness (MCF) of EXTEM

    Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

    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.

Secondary outcomes

  1. Clotting Time (CT)

    Time frame: 10 minutes after induction of anesthesia

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  2. Clotting Time (CT)

    Time frame: 1 minutes after rewarming (during CPB)

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  3. Clotting Time (CT)

    Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

    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.

  4. Clot Formation Time (CFT)

    Time frame: 10 minutes after induction of anesthesia

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  5. Clot Formation Time (CFT)

    Time frame: 1 minutes after rewarming (during CPB)

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  6. Clot Formation Time (CFT)

    Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

    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.

  7. A10

    Time frame: 10 minutes after induction of anesthesia

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  8. A10

    Time frame: 1 minutes after rewarming (during CPB)

    Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  9. A10

    Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

    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.

  10. Maximal Clot firmness (MCF)

    Time frame: 10 minutes after induction of anesthesia

    CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  11. Maximal Clot firmness (MCF)

    Time frame: 1 minutes after rewarming (during CPB)

    CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)

  12. Maximal Clot firmness (MCF)

    Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)

    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.

  13. the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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