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Not yet recruiting NCT06664320

Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

No phase Interventional Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6).
Who it may be relevant to
Registry conditions: Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation. Basic parameters: 19 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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)

Primary outcome measures

  • Maximal clot firmness of EXTEM [Time frame: 10 min after completion of acute normovolemic hemodilution (ANH)]
Secondary outcome measures (2)
  • Clot formation time of EXTEM [Time frame: 10 min after completion of acute normovolemic hemodilution]
  • A10 of FIBTEM [Time frame: 10 min after completion of acute normovolemic hemodilution]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

South Korea · 2 centers
  • Konkuk University Medical Center — Seoul
  • Konkuk University Medical Center — Seoul

Identifiers

NCT: NCT06664320 · KUH1160030-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗