Clinical trial NCT03930355: Perioperative Transfusion Related Outcome
Official title: Effect of Perioperative Transfusion on Early and Late Outcome After Major Elective Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Transfusion
Keywords: Surgery
Perioperative
Transfusion
Mortality
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 6121
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: Inclusion Criteria:

• Patients undergoing major elective surgery

Exclusion Criteria:

• Trauma patients, emergency surgery

Primary outcomes:
measure: 1 year all cause mortality
timeFrame: postoperative 366th day
measure: Acute kidney injury
timeFrame: postoperative 30th day
measure: Acute respiratory failure
timeFrame: postoperative 30th day
measure: Thromboembolic event
timeFrame: postoperative 30th day
measure: Ischemic event
timeFrame: postoperative 30th day
measure: Infection
timeFrame: postoperative 30th day
measure: Myocardial infarction
timeFrame: postoperative 30th day
measure: Adverse cardiac event
timeFrame: postoperative 30th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Teaching and Research Hospital
city: Ankara
country: Turkey
facility: Acibadem University Mehmet Ali Aydinlar Atakent Hospital
city: Ankara
country: Turkey
facility: Ankara University Cebeci Medical Center
city: Ankara
country: Turkey
facility: Ankara University Ibni Sina Hospital
city: Ankara
country: Turkey
facility: Başkent University Ankara Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Private Cankaya Hospital
city: Ankara
country: Turkey
facility: Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Ankara Numune Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Ankara Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Kecioren Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Yenimahalle Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital
city: Ankara
country: Turkey
facility: University of Technology and Economics Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Antalya
country: Turkey
facility: University of Health Sciences Antalya Training and Research Hospital
city: Balıkesir
country: Turkey
facility: Balikesir University Training and Research Hospital
city: Bursa
country: Turkey
facility: Uludağ University Medical Faculty
city: Bursa
country: Turkey
facility: University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Elazığ
country: Turkey
facility: Fırat University Medical Faculty
city: Erzincan
country: Turkey
facility: Erzincan University Mengucek Gazi Training and Research Hospital
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty
city: Isparta
country: Turkey
facility: Suleyman Demirel University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem University Altunizade Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Haydarpasa Numne Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Istanbul Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Okmeydanı Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences Umraniye Training and Research Hospital
city: İzmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: İzmir
country: Turkey
facility: University of Health Sciences Bozyaka Training Research Hospital
city: İzmir
country: Turkey
facility: University of Health Sciences İzmir Tepecik Training and Research Hospital
city: Kahramanmaraş
country: Turkey
facility: Sutcu Imam University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Kocaeli
country: Turkey
facility: Anadolu Health Center Hospital
city: Kocaeli
country: Turkey
facility: University of Health Sciences Derince Training and Research Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty Center for Health and Research
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty
city: Konya
country: Turkey
facility: University of Health Sciences Konya Training and Research Hospital
city: Malatya
country: Turkey
facility: Inonu University Liver Transplantation Institute
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Ordu
country: Turkey
facility: Ordu University Medical Faculty
city: Osmaniye
country: Turkey
facility: Osmaniye State Hospital
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Medical Faculty
city: Tekirdağ
country: Turkey
facility: Namık Kemal University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty Farabi Hospital
city: Tunceli
country: Turkey
facility: Tunceli State Hospital
city: Van
country: Turkey
facility: Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center
city: Zonguldak
country: Turkey
facility: Bulent Ecevit University Medical Faculty Center for Health and Research
city: Çorum
country: Turkey
facility: Hitit University Corum Erol Olcok Training and Research Hospital
Study officials:
affiliation: Ministry of Health
name: Dilek Ünal
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.