Cardiac SurgeryNCT04239677
Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
A study testing Conventional crystalloid solution-based priming and Retrograde autologous priming in people with Cardiac Surgery and Vascular Surgery Using CPB, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Surgery, Vascular Surgery Using CPB
- What is being tested?
- Conventional crystalloid solution-based priming and Retrograde autologous priming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2020to 3 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
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
- Being tested
- Conventional crystalloid solution-based priming, Retrograde autologous priming
- Keywords
- retrograde autologous priming, ROTEM, Cardiac surgery, Vasculsr surgery using CPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional crystalloid solution-based primingProcedure or surgery
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 primingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Conventional crystalloid solution-based priming Receives: Procedure: Conventional crystalloid solution-based priming |
| RAP | Experimental | Retrograde autologous priming Receives: Procedure: Retrograde autologous priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Secondary outcomes (13)
Clotting Time (CT)
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 10 minutes after induction of anesthesia
Clotting Time (CT)
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 1 minutes after rewarming (during CPB)
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.
Measured: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Clot Formation Time (CFT)
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 10 minutes after induction of anesthesia
Clot Formation Time (CFT)
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 1 minutes after rewarming (during CPB)
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.
Measured: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
A10
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 10 minutes after induction of anesthesia
A10
Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 1 minutes after rewarming (during CPB)
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.
Measured: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Maximal Clot firmness (MCF)
CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 10 minutes after induction of anesthesia
Maximal Clot firmness (MCF)
CT, CFT, A10, MCF - Additional parameters assessed by ROTEM (INTEM, EXTEM, FibTEM)
Measured: 1 minutes after rewarming (during CPB)
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.
Measured: 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.
plasma product transfusion - the number of patients who received plasma product transfusion including fresh frozen plasma, cryoprecipitate and platelet concentrate.
Measured: postoperative 48 hours for plasma product transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start6 Feb 2020
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239677
- Sponsor's protocol ID
- 4-2019-1088
- Status last verified
- Sep 2021
- First submitted
- 14 Jan 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04239677
- Acronym / sponsor ID
- 4-2019-1088
- Conditions
- Cardiac Surgery, Vascular Surgery Using CPB
- Keywords
- retrograde autologous priming, ROTEM, Cardiac surgery, Vasculsr surgery using CPB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized trial with 2 parallel groups; the retrograde autologous priming group and conventional crystalloid solution-based priming group.
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Procedure: Conventional crystalloid solution-based primingConventional crystalloid solution-based priming |
| RAP | Experimental | Procedure: Retrograde autologous primingRetrograde autologous priming |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 20 years of age undergoing cardiac surgery / vascular surgery using CPB
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional crystalloid solution-based primingCPB 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). | Procedure or surgery | control |
| Retrograde autologous primingCPB 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. | Procedure or surgery | RAP |
Primary outcome
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.
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.
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.
13 secondary outcomes
Clotting Time (CT)
Time frame: 10 minutes after induction of anesthesia
Clotting Time (CT)
Time frame: 1 minutes after rewarming (during CPB)
Clotting Time (CT)
Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Clot Formation Time (CFT)
Time frame: 10 minutes after induction of anesthesia
Clot Formation Time (CFT)
Time frame: 1 minutes after rewarming (during CPB)
Clot Formation Time (CFT)
Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
A10
Time frame: 10 minutes after induction of anesthesia
A10
Time frame: 1 minutes after rewarming (during CPB)
A10
Time frame: 15 minutes after injection of protamine (after cessation of CPB for reversal of heparin)
Maximal Clot firmness (MCF)
Time frame: 10 minutes after induction of anesthesia
Maximal Clot firmness (MCF)
Time frame: 1 minutes after rewarming (during CPB)
Maximal Clot firmness (MCF)
Time frame: 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.
Time frame: postoperative 48 hours for plasma product transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional crystalloid solution-based priming and Retrograde autologous priming in people with Cardiac Surgery and Vascular Surgery Using CPB, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Clot firmness (MCF) of Externally activated ROTEM assay (EXTEM) (time frame: 10 minutes after induction of anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.