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Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

ConditionsMitral RegurgitationMitral StenosisTricuspid Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorKonkuk University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

Disqualifiers

preoperative renal failure requiring reran replacement therapy

preoperative liver disease

preoperative low cardiac output (EF < 50%)

Preoperative IABP application, Atrial fibrillation, Pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acute normovolemic hemodilution (ANH)

    Procedure/Surgery

    applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass

  • hydroxyethyl starch (HES 130/0.6)

    Drug

    hydroxyethyl starch (HES 130/0.6)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Acute normovolemic hemodilution groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Maximal clot firmness of EXTEM

Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry

Time frame
10 min after completion of acute normovolemic hemodilution (ANH)

Secondary outcomes

1

Clot formation time of EXTEM

Clot formation time of EXTEM of rotational thromboleastometry

Time frame
10 min after completion of acute normovolemic hemodilution
2

A10 of FIBTEM

A10 of FIBTEM of rotational thromboelastometry

Time frame
10 min after completion of acute normovolemic hemodilution

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Konkuk University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: