Haematologic Predictors and Clinical Outcome in Cardiac S... | NCT02653885

Studies
Haematologic Predictors and Clinical Outcome in Cardiac Surgery

NCT02653885

Sponsor

Ankara University

Status

Completed

Last Update Posted

Jan 13, 2016Estimated

Enrollment

1,500Actual

Phase

Not provided

Conditions

Cardiac Disease

Interventions

Red red cell distribution width

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 11, 2016

First Submission Date that Met QC Criteria

Jan 11, 2016

First Posted Date

Jan 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The outcome predictors for cardiac surgery has been popular for many researchers and clinicians. Determining risk factors before surgery reduce morbidity and mortality after surgery. Some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Red red cell distribution width	Other	Results from hemogram		Mean platelet volume Platelet/lymphocyte ratio Neutrophil/lymphocyte ratio

Measure	Description	Time Frame
incidence of combined adverse effects		48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective, on-pump cardiac surgery

Exclusion Criteria:

emergent cases
pediatric cases
congenital surgery
heart transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

cardiac patients needed cardiac surgery

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
CIGDEM YILDIRIM GUCLU, MD	Ankara University	Study Chair

ID	Term
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D004909	Erythrocyte Indices
D063847	Mean Platelet Volume
D010976	Platelet Count

Ancestor Terms

ID	Term
D006403	Hematologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided