NCT03468738

Brief Summary

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey. The transfusion rates of red blood cells (RBC), fresh frozen plasma (FFP) and platelets; the transfusion predictors and transfusion related patient outcomes are investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

61 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

March 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

March 11, 2018

Last Update Submit

April 24, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Preoperative amount of blood products transfused

    Preoperative amount of blood products: RBCs,FFP and platelets transfused

    Before surgery at day 0

  • Intraoperative amount of blood products transfused

    Intraoperative amount of blood products: RBC's,FFP and platelets transfused

    During surgery at day 0

  • Postoperative amount of blood products transfused

    Postoperative amount of blood products: RBCs,FFP and platelets transfused

    24 hours after surgery

Secondary Outcomes (17)

  • Preoperative transfusion indications

    Before surgery at day 0

  • Intraoperative transfusion indications

    During surgery at day 1

  • Postoperative transfusion indications

    24 hours after surgery

  • Unanticipated ICU admission

    After surgery at day 1

  • Prolonged length of stay in ICU

    After surgery at day 2

  • +12 more secondary outcomes

Interventions

Transfusion of blood products in the perioperative period in patients undergoing major surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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 (61)

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 Medeniyet University Goztepe Training and Research 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

University of Health Sciences Kayseri Training and Research Hospital

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 (5)

  • 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.

    PMID: 22593128BACKGROUND
  • 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
  • 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.

    PMID: 17998460BACKGROUND
  • Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

    PMID: 9699234BACKGROUND
  • 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

MeSH Terms

Conditions

Blood Loss, SurgicalAnemiaHemostatic Disorders

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dilek Unal, Assoc Prof

    Netherlands: Ministry of Health, Welfare and Sports

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 19, 2018

Study Start

April 2, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 25, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations