NCT05341037

Brief Summary

It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

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

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

16 days

First QC Date

April 17, 2022

Last Update Submit

August 5, 2022

Conditions

Cardiac Surgery

Keywords

red cell distribution widthlymphocytepostoperative complicationscardiac surgery

Outcome Measures

Primary Outcomes (3)

  • red cell distribution width (RDW)

    preoperative measurement of complete blood count. RDW is calculated by dividing the standard deviation of the mean cell size by the MCV of the red cells and multiplying by 100 to convert to a percentage.

    preoperative period ( 24 hours before surgery)

  • lymphocyte count

    preoperative measurement of complete blood count.

    preoperative period ( 24 hours before surgery)

  • Complications

    postoperative complications such as pulmonary, neurologic, cardiac, infectious.

    postoperative periods, up to 7 days

Study Arms (2)

Postoperative complications +

Patients who have postoperative complications during hospital stay after cardiac surgery

Postoperative complications -

Patients who have not postoperative complications during hospital stay after cardiac surgery

Eligibility Criteria

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

Patients who have undergone open-heart surgery with cardiopulmonary bypass in our hospital within the last year will be evaluated retrospectively.

You may qualify if:

  • Adult patients undergoing open-heart surgery with cardiopulmonary bypass

You may not qualify if:

  • Re-operations
  • Emergency operations
  • Patients with preoperative renal failure
  • Patients with preoperative hematological problems
  • Patients with preoperative infection
  • Patients with preoperative immunological disease
  • Patients using preoperative steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Aydinli B, Demir A, Guclu CY, Bolukbasi D, Unal EU, Koculu R, Selcuk G. Hematological predictors and clinical outcomes in cardiac surgery. J Anesth. 2016 Oct;30(5):770-8. doi: 10.1007/s00540-016-2197-y. Epub 2016 Jun 9.

    PMID: 27282623RESULT

  • Unal EU, Ozen A, Kocabeyoglu S, Durukan AB, Tak S, Songur M, Kervan U, Birincioglu CL. Mean platelet volume may predict early clinical outcome after coronary artery bypass grafting. J Cardiothorac Surg. 2013 Apr 16;8:91. doi: 10.1186/1749-8090-8-91.

    PMID: 23590976RESULT

  • Huang J, Zhao Y, Liao L, Liu S, Lu S, Wu C, Wei C, Xu S, Zhong H, Liu J, Guo Y, Zhang S, Gao F, Tang W. Evaluation of Red Cell Distribution Width to Lymphocyte Ratio as Potential Biomarker for Detection of Colorectal Cancer. Biomed Res Int. 2019 Jul 31;2019:9852782. doi: 10.1155/2019/9852782. eCollection 2019.

    PMID: 31467924RESULT

  • Ma C, Liu Q, Li C, Cheng J, Liu D, Yang Z, Yan H, Wu B, Wu Y, Zhao J. Novel Blood Indicators of Progression and Prognosis in Renal Cell Carcinoma: Red Cell Distribution Width-to-Lymphocyte Ratio and Albumin-to-Fibrinogen Ratio. J Oncol. 2020 Nov 25;2020:2895150. doi: 10.1155/2020/2895150. eCollection 2020.

    PMID: 33299415RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ZELİHA A DEMİR, Professor

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

June 15, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

TU(1)