Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

Konkuk University Medical Center

Status: Not yet enrolling

Conditions: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation

Treatments: Procedure: Acute normovolemic hemodilution (ANH); Drug: hydroxyethyl starch (HES 130/0.6)

Study type: Interventional

Funder types: Other

Identifiers

NCT06664320

KUH1160030-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control group

No Intervention group

Description:

patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB

Acute normovolemic hemodilution group

Active Comparator group

Description:

patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB

Treatment:

Drug: hydroxyethyl starch (HES 130/0.6)

Procedure: Acute normovolemic hemodilution (ANH)