Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Primary Purpose
Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acute normovolemic hemodilution (ANH)
hydroxyethyl starch (HES 130/0.6)
Sponsored by
About this trial
This is an interventional supportive care trial for Mitral Regurgitation focused on measuring rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution
Eligibility Criteria
Inclusion Criteria:
- patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Exclusion Criteria:
- preoperative renal failure requiring reran replacement therapy
- preoperative liver disease
- preoperative low cardiac output (EF < 50%)
- Preoperative IABP application, Atrial fibrillation, Pacemaker,
- contraindication for applying TEE
- intraoperative withdrawal
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control group
Acute normovolemic hemodilution group
Arm Description
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Outcomes
Primary Outcome Measures
Maximal clot firmness of EXTEM
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
Secondary Outcome Measures
Clot formation time of EXTEM
Clot formation time of EXTEM of rotational thromboleastometry
A10 of FIBTEM
A10 of FIBTEM of rotational thromboelastometry
Full Information
NCT ID
NCT02502448
First Posted
March 3, 2015
Last Updated
January 28, 2020
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02502448
Brief Title
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Official Title
Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.
After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Detailed Description
Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
Keywords
rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
Arm Title
Acute normovolemic hemodilution group
Arm Type
Active Comparator
Arm Description
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Intervention Type
Procedure
Intervention Name(s)
Acute normovolemic hemodilution (ANH)
Intervention Description
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
hydroxyethyl starch (HES 130/0.6)
Primary Outcome Measure Information:
Title
Maximal clot firmness of EXTEM
Description
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
Time Frame
10 min after completion of acute normovolemic hemodilution (ANH)
Secondary Outcome Measure Information:
Title
Clot formation time of EXTEM
Description
Clot formation time of EXTEM of rotational thromboleastometry
Time Frame
10 min after completion of acute normovolemic hemodilution
Title
A10 of FIBTEM
Description
A10 of FIBTEM of rotational thromboelastometry
Time Frame
10 min after completion of acute normovolemic hemodilution
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Exclusion Criteria:
preoperative renal failure requiring reran replacement therapy
preoperative liver disease
preoperative low cardiac output (EF < 50%)
Preoperative IABP application, Atrial fibrillation, Pacemaker,
contraindication for applying TEE
intraoperative withdrawal
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
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Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
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