NCT06835257

Brief Summary

In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical method (PRAM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

August 22, 2023

Last Update Submit

February 17, 2025

Conditions

Coronary Artery Bypass GraftingAcute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (1)

  • Comparison of the effects of different techniques used for autologous blood collection on Cardiac Cycle Efficiency (CCE) changes obtained by pulse contour analysis.

    Difference of Cardiac Cycle Efficiency(CCE) PRAM parameters between patients

    From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)

Secondary Outcomes (1)

  • Comparison of the Contractility (dP/dtmax mmHg/msec), Stroke Volume Index (SVI mL/m2), Cardiac Power Index (CPI W/m2), Arterial Elastance (Ea mmHg/mL), Stroke Volume Variation (SVV %), Pulse Pressure Variation (PPV %) changes

    From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)

Study Arms (2)

Acute normovolemic hemodilution

ACTIVE COMPARATOR

Acute normovolemic hemodilution throughout the autologous blood collection

Procedure: Acute normovolemic hemodilutions

Vasopressor

ACTIVE COMPARATOR

Vasopressor infusion throughout the autologous blood collection

Drug: Vasopressor infusion

Interventions

Acute normovolemic hemodilutionsPROCEDURE

Crystalloid infusion throughout the autologous blood collection (3 ml of crystalloid infusion for every 1 ml of blood)

Acute normovolemic hemodilution
Vasopressor infusionDRUG

Vasopressor infusion throughout the autologous blood collection (according to mean arterial pressure)

Vasopressor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 18 years
  • Undergoing isolated coronary artery bypass grafting surgery under general anesthesia
  • Invasive blood pressure (radial or femoral) and Mostcare monitoring
  • Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery
  • Ability and willingness to provide informed consent

You may not qualify if:

  • Refuse to consent to the study
  • Arterial wave form distortion
  • Cardiac arrhythmia
  • Inappropriate identification of the dicrotic notch for any reason
  • Hemodynamic instability defined as mean arterial blood pressure \< 65 mmHg
  • Preoperative requirement of inotrope/vasopressor infusion
  • Preoperatively receiving vasoactive drugs
  • Patients fitted with an intra-aortic balloon pump
  • Patients fitted with Extracorporeal Membrane Oxygenation
  • Critically ill patients requiring preoperative intensive care unit
  • Presence of intraabdominal hypertension
  • New York Heart Association Class 3-4 heart failure
  • Congestive heart failure with ejection fraction \< 35%
  • Glomerular filtration rate \< 30 ml/min/1.73 m2
  • Ongoing renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (3)

  • Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.

    PMID: 20940382BACKGROUND

  • Coursin DB, Monk TG. Extreme normovolemic hemodilution: how low can you go and other alternatives to transfusion? Crit Care Med. 2001 Apr;29(4):908-10. doi: 10.1097/00003246-200104000-00051. No abstract available.

    PMID: 11373498BACKGROUND

  • Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med. 2002 Aug;30(8):1834-41. doi: 10.1097/00003246-200208000-00027.

    PMID: 12163802BACKGROUND

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2023

First Posted

February 19, 2025

Study Start

June 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)