Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Not Applicable

Completed

• Conditions: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation
• Interventions: Procedure: Acute normovolemic hemodilution (ANH); Drug: hydroxyethyl starch (HES 130/0.6)

• Registration Number: NCT02502448
• Lead Sponsor: Konkuk University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute normovolemic hemodilution group	Acute normovolemic hemodilution (ANH)	patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Acute normovolemic hemodilution group	hydroxyethyl starch (HES 130/0.6)	patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB

Primary Outcome Measures

Name	Time	Method
Maximal clot firmness of EXTEM	10 min after completion of acute normovolemic hemodilution (ANH)	Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of