Perioperative Transfusion Related Outcome

September 23, 2021 updated by: DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Effect of Perioperative Transfusion on Early and Late Outcome After Major Elective Surgery

A secondary analysis of the Turkish National Perioperative Transfusion Study (TULIP TS) database will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Turkish National Perioperative Transfusion Study (TULIP TS) was conducted by The Turkish Society of Anesthesiologists' Multicentre Clinical Trials Network.

TULIP TS included 6481 patients undergoing major elective surgery, from 61 study sites across the country.

Transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and patient blood management strategies; the areas for improvement and the obstacles that could prevent change were evaluated and identified.

Data relevant to perioperative transfusion rates of red blood cells, fresh frozen plasma and platelets, the indications for transfusion and postoperative adverse outcomes including 1 month all cause mortality was obtained.

The TULIP TS group aims to collect further data concerning 1 year all cause mortality of the same patient population and to evaluate adverse outcomes in transfused and non transfused patients.

Study Type

Observational

Enrollment (Actual)

6121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University Medical Faculty
      • Ankara, Turkey
        • Hacettepe University Medical Faculty
      • Ankara, Turkey
        • Ankara University Ibni Sina Hospital
      • Ankara, Turkey
        • Baskent University Ankara Hospital
      • Ankara, Turkey
        • Acibadem University Mehmet Ali Aydinlar Atakent Hospital
      • Ankara, Turkey
        • Ankara University Cebeci Medical Center
      • Ankara, Turkey
        • Private Cankaya Hospital
      • Ankara, Turkey
        • Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital
      • Ankara, Turkey
        • University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital
      • Ankara, Turkey
        • University of Health Sciences Ankara Numune Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Ankara Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Kecioren Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Yenimahalle Training and Research Hospital
      • Ankara, Turkey
        • University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital
      • Ankara, Turkey
        • University of Technology and Economics Medical Faculty
      • Ankara, Turkey, 06610
        • Diskapi Yildirim Beyazit Teaching and Research Hospital
      • Antalya, Turkey
        • Akdeniz University Medical Faculty
      • Antalya, Turkey
        • University of Health Sciences Antalya Training and Research Hospital
      • Balıkesir, Turkey
        • Balikesir University Training and Research Hospital
      • Bursa, Turkey
        • Uludag University Medical Faculty
      • Bursa, Turkey
        • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
      • Edirne, Turkey
        • Trakya University Medical Faculty
      • Elazığ, Turkey
        • Fırat University Medical Faculty
      • Erzincan, Turkey
        • Erzincan University Mengucek Gazi Training and Research Hospital
      • Eskişehir, Turkey
        • Eskisehir Osmangazi University Medical Faculty
      • Isparta, Turkey
        • Suleyman Demirel University Medical Faculty
      • Istanbul, Turkey
        • Istanbul University Medical Faculty
      • Istanbul, Turkey
        • Marmara University Pendik Training and Research Hospital
      • Istanbul, Turkey
        • Acibadem University Altunizade Hospital
      • Istanbul, Turkey
        • University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital
      • Istanbul, Turkey
        • University of Health Sciences Haydarpasa Numne Training and Research Hospital
      • Istanbul, Turkey
        • University of Health Sciences Istanbul Training and Research Hospital
      • Istanbul, Turkey
        • University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
      • Istanbul, Turkey
        • University of Health Sciences Okmeydanı Training and Research Hospital
      • Istanbul, Turkey
        • University of Health Sciences Umraniye Training and Research Hospital
      • Kahramanmaraş, Turkey
        • Sutcu Imam University Medical Faculty
      • Kayseri, Turkey
        • Erciyes University Medical Faculty
      • Kocaeli, Turkey
        • Anadolu Health Center Hospital
      • Kocaeli, Turkey
        • University of Health Sciences Derince Training and Research Hospital
      • Konya, Turkey
        • Selcuk University Medical Faculty
      • Konya, Turkey
        • Necmettin Erbakan University Meram Medical Faculty Center for Health and Research
      • Konya, Turkey
        • University of Health Sciences Konya Training and Research Hospital
      • Malatya, Turkey
        • Inonu University Liver Transplantation Institute
      • Manisa, Turkey
        • Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital
      • Mersin, Turkey
        • Mersin University Medical Faculty
      • Ordu, Turkey
        • Ordu University Medical Faculty
      • Osmaniye, Turkey
        • Osmaniye State Hospital
      • Samsun, Turkey
        • Ondokuz Mayıs University Medical Faculty
      • Tekirdağ, Turkey
        • Namık Kemal University Medical Faculty
      • Trabzon, Turkey
        • Karadeniz Technical University Medical Faculty Farabi Hospital
      • Tunceli, Turkey
        • Tunceli State Hospital
      • Van, Turkey
        • Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center
      • Zonguldak, Turkey
        • Bulent Ecevit University Medical Faculty Center for Health and Research
      • Çorum, Turkey
        • Hitit University Corum Erol Olcok Training and Research Hospital
      • İzmir, Turkey
        • Dokuz Eylul University Medical Faculty
      • İzmir, Turkey
        • University of Health Sciences Bozyaka Training Research Hospital
      • İzmir, Turkey
        • University of Health Sciences Izmir Tepecik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery

Description

Inclusion Criteria:

• Patients undergoing major elective surgery

Exclusion Criteria:

• Trauma patients, emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transfused
Patients who received blood transfusion in the perioperative period
Other: Blood transfusion
Patients who received blood transfusion in the perioperative period
Non transfused
Patients who did not receive blood transfusion in the perioperative period
Other: Control
Patients who did not receive blood transfusion in the perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year all cause mortality
Time Frame: postoperative 366th day
Number of participants died: all cause mortality
postoperative 366th day
Acute kidney injury
Time Frame: postoperative 30th day
Number of participants with acute kidney injury
postoperative 30th day
Acute respiratory failure
Time Frame: postoperative 30th day
Number of participants with acute respiratory failure
postoperative 30th day
Thromboembolic event
Time Frame: postoperative 30th day
Number of participants with a thromboembolic event
postoperative 30th day
Ischemic event
Time Frame: postoperative 30th day
Number of participants with an ischemic event
postoperative 30th day
Infection
Time Frame: postoperative 30th day
Number of participants with infection
postoperative 30th day
Myocardial infarction
Time Frame: postoperative 30th day
Number of participants with myocardial infarction
postoperative 30th day
Adverse cardiac event
Time Frame: postoperative 30th day
Number of participants with an adverse cardiac event
postoperative 30th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Dilek Ünal, Ministry of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (ACTUAL)

April 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TULIP TS II

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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