Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Scoring Systems for Bleeding in Open Cardiac Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03846622
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ipek Yakin Duzyol, Kocaeli Derince Education and Research Hospital

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.

Condition or disease Intervention/treatment
Bleeding 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Preoperative Scoring Systems for Prediction of Perioperative Bleeding in Patients To Be Operated for Open Cardiac Surgery
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Bleeding scores [ Time Frame: Bleeding risk scores were calculated through study completion, an average of 2 years. ]
    Bleeding scores were calculated in points ranging from 0 to 4.(0 the lowest and 4 the highest risk score for bleeding)

  2. The amount of blood transfusions [ Time Frame: The amount of blood transfusions were recorded through study completion, an average of 2 years. ]
    The amount of blood transfusions were recorded in units.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years of age who were operated for elective open cardiac surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846622


Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Investigators
Layout table for investigator information
Study Director: Tolga Saracoglu Associate professor of the department of anaesthesiology and reanimation

Layout table for additonal information
Responsible Party: Ipek Yakin Duzyol, Principal Investigator, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03846622     History of Changes
Other Study ID Numbers: 18/34
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes