Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
Conditions
Keywords
rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution, hemodilution, coagulation
Brief summary
The 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 are randomly allocated into one of two groups: in Group-ANH, 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, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Detailed description
Background: The 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 are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal 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, and s-Cr are determined Intergroup differences of data at T2 are performed.
Interventions
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
hydroxyethyl starch (HES 130/0.6)
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal clot firmness of EXTEM | 10 min after completion of acute normovolemic hemodilution (ANH) | Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clot formation time of EXTEM | 10 min after completion of acute normovolemic hemodilution | Clot formation time of EXTEM of rotational thromboleastometry |
| A10 of FIBTEM | 10 min after completion of acute normovolemic hemodilution | A10 of FIBTEM of rotational thromboelastometry |
Countries
South Korea
Contacts
Primary ContactTae-Yop Kim, MD, PhD
Backup ContactWooseul Lee, Bachelor
Outcome results
None listed