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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846622
Other study ID # 18/34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2018

Study information

Verified date February 2019
Source Kocaeli Derince Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Calculation of scoring systems for bleeding


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli Derince Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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