Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502448
• Other study ID #: KUH1160030
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2020
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Insufficiency
• Mitral Valve Stenosis
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal clot firmness of EXTEM	Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry	10 min after completion of acute normovolemic hemodilution (ANH)
Secondary	Clot formation time of EXTEM	Clot formation time of EXTEM of rotational thromboleastometry	10 min after completion of acute normovolemic hemodilution
Secondary	A10 of FIBTEM	A10 of FIBTEM of rotational thromboelastometry	10 min after completion of acute normovolemic hemodilution