NCT03930355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,121

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

60 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 24, 2021

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

April 24, 2019

Last Update Submit

September 23, 2021

Conditions

Keywords

SurgeryPerioperativeTransfusionMortality

Outcome Measures

Primary Outcomes (8)

  • 1 year all cause mortality

    Number of participants died: all cause mortality

    postoperative 366th day

  • Acute kidney injury

    Number of participants with acute kidney injury

    postoperative 30th day

  • Acute respiratory failure

    Number of participants with acute respiratory failure

    postoperative 30th day

  • Thromboembolic event

    Number of participants with a thromboembolic event

    postoperative 30th day

  • Ischemic event

    Number of participants with an ischemic event

    postoperative 30th day

  • Infection

    Number of participants with infection

    postoperative 30th day

  • Myocardial infarction

    Number of participants with myocardial infarction

    postoperative 30th day

  • Adverse cardiac event

    Number of participants with an adverse cardiac event

    postoperative 30th day

Study Arms (2)

Transfused

Patients who received blood transfusion in the perioperative period

Other: Blood transfusion

Non transfused

Patients who did not receive blood transfusion in the perioperative period

Other: Control

Interventions

Patients who received blood transfusion in the perioperative period

Transfused
ControlOTHER

Patients who did not receive blood transfusion in the perioperative period

Non transfused

Eligibility Criteria

Age1 Day - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients undergoing major elective surgery

You may not qualify if:

  • Trauma patients, emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, 06610, Turkey (Türkiye)

Location

Acibadem University Mehmet Ali Aydinlar Atakent Hospital

Ankara, Turkey (Türkiye)

Location

Ankara University Cebeci Medical Center

Ankara, Turkey (Türkiye)

Location

Ankara University Ibni Sina Hospital

Ankara, Turkey (Türkiye)

Location

Başkent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Private Cankaya Hospital

Ankara, Turkey (Türkiye)

Location

Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Ankara Numune Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Kecioren Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Yenimahalle Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

University of Technology and Economics Medical Faculty

Ankara, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Location

University of Health Sciences Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Balikesir University Training and Research Hospital

Balıkesir, Turkey (Türkiye)

Location

Uludağ University Medical Faculty

Bursa, Turkey (Türkiye)

Location

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Hitit University Corum Erol Olcok Training and Research Hospital

Çorum, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Location

Fırat University Medical Faculty

Elâzığ, Turkey (Türkiye)

Location

Erzincan University Mengucek Gazi Training and Research Hospital

Erzincan, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty

Eskişehir, Turkey (Türkiye)

Location

Suleyman Demirel University Medical Faculty

Isparta, Turkey (Türkiye)

Location

Acibadem University Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Haydarpasa Numne Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Okmeydanı Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Location

University of Health Sciences Bozyaka Training Research Hospital

Izmir, Turkey (Türkiye)

Location

University of Health Sciences İzmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Sutcu Imam University Medical Faculty

Kahramanmaraş, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, Turkey (Türkiye)

Location

Anadolu Health Center Hospital

Kocaeli, Turkey (Türkiye)

Location

University of Health Sciences Derince Training and Research Hospital

Kocaeli, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty Center for Health and Research

Konya, Turkey (Türkiye)

Location

Selcuk University Medical Faculty

Konya, Turkey (Türkiye)

Location

University of Health Sciences Konya Training and Research Hospital

Konya, Turkey (Türkiye)

Location

Inonu University Liver Transplantation Institute

Malatya, Turkey (Türkiye)

Location

Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital

Manisa, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Location

Ordu University Medical Faculty

Ordu, Turkey (Türkiye)

Location

Osmaniye State Hospital

Osmaniye, Turkey (Türkiye)

Location

Ondokuz Mayıs University Medical Faculty

Samsun, Turkey (Türkiye)

Location

Namık Kemal University Medical Faculty

Tekirdağ, Turkey (Türkiye)

Location

Karadeniz Technical University Medical Faculty Farabi Hospital

Trabzon, Turkey (Türkiye)

Location

Tunceli State Hospital

Tunceli, Turkey (Türkiye)

Location

Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center

Van, Turkey (Türkiye)

Location

Bulent Ecevit University Medical Faculty Center for Health and Research

Zonguldak, Turkey (Türkiye)

Location

Related Publications (4)

  • Meier J, Filipescu D, Kozek-Langenecker S, Llau Pitarch J, Mallett S, Martus P, Matot I; ETPOS collaborators. Intraoperative transfusion practices in Europe. Br J Anaesth. 2016 Feb;116(2):255-61. doi: 10.1093/bja/aev456.

    PMID: 26787795BACKGROUND
  • Kalil AC, Mattei J, Florescu DF, Sun J, Kalil RS. Recommendations for the assessment and reporting of multivariable logistic regression in transplantation literature. Am J Transplant. 2010 Jul;10(7):1686-94. doi: 10.1111/j.1600-6143.2010.03141.x.

    PMID: 20642690BACKGROUND
  • Kotze A, Carter LA, Scally AJ. Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth. 2012 Jun;108(6):943-52. doi: 10.1093/bja/aes135.

  • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dilek Ünal

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

May 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

September 24, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations