Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02502448

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation	Procedure: Acute normovolemic hemodilution (ANH) Drug: hydroxyethyl starch (HES 130/0.6)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
Active Comparator: Acute normovolemic hemodilution group patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB	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)

Arm

Intervention/Treatment

No Intervention: Control group

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

Active Comparator: Acute normovolemic hemodilution group

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

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)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konkuk University Medical Center	Seoul		Korea, Republic of	143-729

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT02502448

Other Study ID Numbers:

KUH1160030

First Posted:

Jul 20, 2015

Last Update Posted:

Jan 30, 2020

Last Verified:

Jan 1, 2020

Keywords provided by Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center

rotational thromboelastometry

cardiac surgery

acute normovolemic hemodilution

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Tricuspid Valve Insufficiency

Mitral Valve Stenosis

Study Results

No Results Posted as of Jan 30, 2020