Clinical trial NCT06664320: Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
Official title: Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Stenosis
Tricuspid Regurgitation
Keywords: rotational thromboelastometry
cardiac surgery
acute normovolemic hemodilution
hemodilution
coagulation
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Maximal clot firmness of EXTEM
timeFrame: 10 min after completion of acute normovolemic hemodilution (ANH)
Secondary outcomes:
measure: Clot formation time of EXTEM
timeFrame: 10 min after completion of acute normovolemic hemodilution
measure: A10 of FIBTEM
timeFrame: 10 min after completion of acute normovolemic hemodilution
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: