Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

October 30, 2024 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tae-Yop Kim, MD, PhD
  • Phone Number: +82-2-2030-5445
  • Email: taeyop@gmail.com

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)
hydroxyethyl starch (HES 130/0.6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal clot firmness of EXTEM
Time Frame: 10 min after completion of acute normovolemic hemodilution (ANH)
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
10 min after completion of acute normovolemic hemodilution (ANH)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clot formation time of EXTEM
Time Frame: 10 min after completion of acute normovolemic hemodilution
Clot formation time of EXTEM of rotational thromboleastometry
10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM
Time Frame: 10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM of rotational thromboelastometry
10 min after completion of acute normovolemic hemodilution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 28, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160030-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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