Comparison of Scoring Systems for Bleeding in Open Cardia... | NCT03846622

Studies
Comparison of Scoring Systems for Bleeding in Open Cardiac Surgery Patients

NCT03846622

Sponsor

Kocaeli Derince Education and Research Hospital

Status

Completed

Last Update Posted

Feb 19, 2019Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Bleeding

Interventions

Calculation of scoring systems for bleeding

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

Feb 2019

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 1, 2016Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jan 13, 2019

First Submission Date that Met QC Criteria

Feb 17, 2019

First Posted Date

Feb 19, 2019Actual

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

Feb 17, 2019

Last Update Posted Date

Feb 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ipek Yakin Duzyol, Principal Investigator, Kocaeli Derince Education and Research HospitalPrincipal Investigator

Lead Sponsor

Kocaeli Derince Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Seven different scoring systems used for prediction of perioperative bleeding were compared regarding patients operated for elective open cardiac surgery in the investigator's study.

Detailed Description

Collected data of 500 consecutive patients, operated for elective open cardiac surgery were analyzed retrospectively. Seven different scoring systems were used to predict the probability of bleeding, including TRACK, PAPWORTH, WILL-BLEED, CRUSADE, ACTION, TRUST and ACTA-PORT. The scores are calculated for each of these systems by using their own parameters, and classified into four risk groups as very low, low, moderate and high. Then, these risk groups were compared with patients identified in two groups regarding the use of perioeprative erythrocyte suspension (ES) transfusions or not, as ES positive and ES negative.

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

500Actual

Name	Type	Description	Arm Group Labels	Other Names
Calculation of scoring systems for bleeding	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding scores	Bleeding scores were calculated in points ranging from 0 to 4.(0 the lowest and 4 the highest risk score for bleeding)	Bleeding risk scores were calculated through study completion, an average of 2 years.
The amount of blood transfusions	The amount of blood transfusions were recorded in units.	The amount of blood transfusions were recorded through study completion, an average of 2 years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with 18 years of age or older,
Patients operated for elective open cardiac surgery.

Exclusion Criteria:

Patients with incomplete data,
Patients with an age less than 18 years,
Patients operated for emergent surgical procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 years of age who were operated for elective open cardiac surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tolga Saracoglu	Associate professor of the department of anaesthesiology and reanimation	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided