NCT03245502

Brief Summary

Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2) will be recorded in several steps in coronary artery bypass graft and valvular cardiac operations. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

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

August 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

August 8, 2017

Last Update Submit

December 14, 2017

Conditions

Keywords

tissue oxygenation

Outcome Measures

Primary Outcomes (1)

  • Complication

    The postoperative neurologic, renal, hepatic, respiratory complications

    5 days

Secondary Outcomes (1)

  • Mortality

    28 days

Study Arms (2)

Transfused

Patients who have blood transfusion during cardiac surgery

Biological: Blood transfusion

Not-Transfused

Patients who don't have blood transfusion during cardiac surgery

Interventions

The transfusion of erythrocyte suspension

Transfused

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-75 years cardiac surgery patients

You may qualify if:

  • Elective cardiac surgery, stable cardiac function

You may not qualify if:

  • Clinical signs of heart failure, symptomatic cerebral or peripheral failure, uncontrolled diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkiye Yuksek Ihtisas Education and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Demet Bölükbaşı, Specialist

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY CHAIR
  • Sema Turan, Asc prof

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY DIRECTOR
  • Dilek Kazancı, Asc prof

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY CHAIR
  • Sultan Sevim Yakın, Specialist

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY CHAIR
  • Hija Yazıcıoğlu, Asc Prof

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY CHAIR
  • Aysegül Özgok, Prof

    Turkiye Yuksek Ihtisas Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist doctor

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 10, 2017

Study Start

August 20, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

December 18, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations