NCT02502448

Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation
• Mitral Stenosis
• Tricuspid Regurgitation

Interventions

Type	Name	Description
PROCEDURE	Acute normovolemic hemodilution (ANH)	applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
DRUG	hydroxyethyl starch (HES 130/0.6)

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-07-20
• Last updated: 2020-01-30

Locations

1 site across 1 country: South Korea