Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

NCT02502448

Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation

COMPLETED NA

Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

NCT02831270

Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation

COMPLETED

Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

NCT01303250

Surgery, Colorectal

TERMINATED PHASE4

The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

NCT02599155

Acute Kidney Injury

COMPLETED NA

Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

NCT07329660

Transcatheter Aortic Valve Replacement Hemodynamic Stability Anesthesia Induction

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Acute normovolemic hemodilution group

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

Group Type ACTIVE_COMPARATOR

Acute normovolemic hemodilution (ANH)

Intervention Type PROCEDURE

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)

Intervention Type DRUG

hydroxyethyl starch (HES 130/0.6)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

hydroxyethyl starch (HES 130/0.6)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No