NCT06484907

Brief Summary

In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
467

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 25, 2024

Last Update Submit

June 22, 2025

Conditions

Keywords

Cardiopulmonary BypassCardiac SurgeryTransfusionAcute Kidney InjuryACTA PORT

Outcome Measures

Primary Outcomes (1)

  • KDIGO AKI Staging

    KDIGO is in the process of developing the Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). ///// Stage 1: Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output \<0.5 ml/kg/h for 6-12 hours ////// Stage 2: Serum creatinine 2.0-2.9 times baseline or \<0.5 ml/kg/h for ≥12 hours /////// Stage 3: Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients \<18 years, decrease in eGFR to \<35 ml/min per 1.73 m² or Urine output \<0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours

    Preoperative (last week before operation) and daily after the operation for 7 days

Secondary Outcomes (6)

  • Mechanical Ventilation Duration

    the duration after surgery up to a month

  • Intensive Care Duration

    the duration after surgery up to a month

  • Hospital Stay Duration

    the duration after surgery up to a month

  • Mortality

    the duration after surgery up to a month

  • Complications

    the duration after surgery up to a month

  • +1 more secondary outcomes

Eligibility Criteria

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

Patients having open heart surgery by using cardiopulmonary bypass pump in Ankara Bilkent City Hospital between 01 July 2024 - 01 November 2024.

You may qualify if:

  • Patients over 18 years old
  • Patients having open heart surgery
  • Patients undergoing surgery by using cardiopulmonary bypass pump

You may not qualify if:

  • Patients under 18 years old
  • Patients diagnosed with kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart DiseasesAcute Kidney Injury

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Zeliha Asli DEMIR, Ph.D

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 3, 2024

Study Start

July 1, 2024

Primary Completion

September 15, 2024

Study Completion

December 1, 2024

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations