Comparison of Scoring Systems for Bleeding in Open Cardiac Surgery Patients

Comparison of Preoperative Scoring Systems for Prediction of Perioperative Bleeding in Patients To Be Operated for Open Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Bleeding
• Intervention / Treatment: Other: Calculation of scoring systems for bleeding

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.

• Study Type: Observational
• Enrollment (Actual): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital
• Investigators: Study Director: Tolga Saracoglu, Associate professor of the department of anaesthesiology and reanimation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: February 17, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 17, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 18/34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No