NCT06873620

Brief Summary

This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

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

February 23, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

March 7, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

on-pump cabgcardiac anesthesiacross clampingcabg complications

Outcome Measures

Primary Outcomes (1)

  • Relationship between CPB/CC time and mortality

    CPB/CC time is the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time in patients undergoing on-pump cardiac surgery.

    From enrollment to the end of treatment at 8 weeks

Study Arms (1)

on-pomp CABG

All eligible patients undergoing on-pump-assisted CABG surgery will be included in this group.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be an observational research conducted in our hospital, involving patients aged 18 to 80 who are undergoing on-pump coronary artery bypass grafting (CABG). The study population will consist of individuals within this age range who are scheduled for elective or urgent on-pump CABG surgery.

You may qualify if:

  • Patients undergoing open heart surgery
  • Undergo on pump surgery

You may not qualify if:

  • Patients undergoing emergency open heart surgery Patients undergoing open heart surgery on a beating heart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (4)

  • Yousefshahi F, Samadi E, Paknejad O, Movafegh A, Barkhordari K, Bastan Hagh E, Dehestani B. Prevalence and Risk Factors of Hypoxemia after Coronary Artery Bypass Grafting: The Time to Change Our Conceptions. J Tehran Heart Cent. 2019 Apr;14(2):74-80.

    PMID: 31723349BACKGROUND
  • Moh'd AF, Al-Odwan HT, Altarabsheh S, Makahleh ZM, Khasawneh MA. Predictors of aortic clamp time duration and intensive care unit length of stay in elective adult cardiac surgery. Egypt Heart J. 2021 Oct 22;73(1):92. doi: 10.1186/s43044-021-00195-0.

    PMID: 34677684BACKGROUND
  • Parmana IMA, Boom CE, Rachmadi L, Hanafy DA, Widyastuti Y, Mansyur M, Siswanto BB. Correlation Between Cardiac Index, Plasma Troponin I, Myocardial Histopathology, CPB and AoX Duration in Glutamine versus No Glutamine Administered Patients with Low Ejection Fraction Undergoing Elective On-Pump CABG Surgery: Secondary Analysis of an RCT. Vasc Health Risk Manag. 2023 Feb 28;19:93-101. doi: 10.2147/VHRM.S399925. eCollection 2023.

    PMID: 36880009BACKGROUND
  • Hadipourzadeh F, Rastravan R, Totonchi Z, Heydarpur E, Faritous Z. Evaluating the relationship between lactate levels during coronary artery bypass graft surgery and postoperative renal dysfunction. J Cardiovasc Thorac Res. 2024;16(2):129-134. doi: 10.34172/jcvtr.33051. Epub 2024 Jun 25.

    PMID: 39253341BACKGROUND

Study Officials

  • Mehmet Yilmaz, Associate Proffessor

    Kocaeli City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

February 23, 2024

Primary Completion

October 1, 2025

Study Completion

October 15, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Sharing IPD is at the discretion of the institution and written permission must be applied to the institution.

Locations