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NCT03930355 Clinical Trial

Perioperative Transfusion Related Outcome

Blood Transfusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03930355
Other study ID # TULIP TS II
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 30, 2020

Study information
Verified date June 2020
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 6121
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 100 Years
Eligibility Inclusion Criteria: • Patients undergoing major elective surgery Exclusion Criteria: • Trauma patients, emergency surgery

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood transfusion
Patients who received blood transfusion in the perioperative period
• Control
Patients who did not receive blood transfusion in the perioperative period

Locations
Country Name City State
Turkey Acibadem University Mehmet Ali Aydinlar Atakent Hospital Ankara
Turkey Ankara University Cebeci Medical Center Ankara
Turkey Ankara University Ibni Sina Hospital Ankara
Turkey Baskent University Ankara Hospital Ankara
Turkey Diskapi Yildirim Beyazit Teaching and Research Hospital Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Hacettepe University Medical Faculty 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 Yurtaslani 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 Akdeniz University Medical Faculty Antalya
Turkey University of Health Sciences Antalya Training and Research Hospital Antalya
Turkey Balikesir University Training and Research Hospital Balikesir
Turkey Uludag University Medical Faculty Bursa
Turkey University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Bursa
Turkey Hitit University Corum Erol Olcok Training and Research Hospital Çorum
Turkey Trakya University Medical Faculty Edirne
Turkey Firat University Medical Faculty Elazig
Turkey Erzincan University Mengucek Gazi Training and Research Hospital Erzincan
Turkey Eskisehir Osmangazi University Medical Faculty Eskisehir
Turkey Suleyman Demirel University Medical Faculty Isparta
Turkey Acibadem University Altunizade Hospital Istanbul
Turkey Istanbul University Medical Faculty Istanbul
Turkey Marmara University Pendik Training and Research 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 Okmeydani Training and Research Hospital Istanbul
Turkey University of Health Sciences Umraniye Training and Research Hospital Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
Turkey University of Health Sciences Bozyaka Training Research Hospital Izmir
Turkey University of Health Sciences Izmir Tepecik Training and Research Hospital Izmir
Turkey Sutcu Imam University Medical Faculty Kahramanmaras
Turkey Erciyes University Medical Faculty Kayseri
Turkey Anadolu Health Center Hospital Kocaeli
Turkey University of Health Sciences Derince Training and Research Hospital Kocaeli
Turkey Necmettin Erbakan University Meram Medical Faculty Center for Health and Research Konya
Turkey Selcuk University Medical Faculty Konya
Turkey University of Health Sciences Konya Training and Research Hospital Konya
Turkey Inonu University Liver Transplantation Institute Malatya
Turkey Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital Manisa
Turkey Mersin University Medical Faculty Mersin
Turkey Ordu University Medical Faculty Ordu
Turkey Osmaniye State Hospital Osmaniye
Turkey Ondokuz Mayis University Medical Faculty Samsun
Turkey Namik Kemal University Medical Faculty Tekirdag
Turkey Karadeniz Technical University Medical Faculty Farabi Hospital Trabzon
Turkey Tunceli State Hospital Tunceli
Turkey Van Yuzuncuyil University Medical Faculty Dursun Odabasi Center Van
Turkey Bulent Ecevit University Medical Faculty Center for Health and Research Zonguldak

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Kotzé 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/bj — View Citation

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. — View Citation

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. Epub 2007 Nov 12. — View Citation

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