Clinical trial NCT03468738: Investigation of the Transfusion Practices in Surgical Patients in Turkey
Official title: Investigation of the Transfusion Practices in Surgical Patients in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Blood Loss, Surgical
Blood Loss Anemia
Blood Transfusion
Anemia
Coagulation Disorder
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
Collaborators: name: Turkish Society of Anesthesiology and Reanimation
First posted: 2018-03-19
Enrollment: 6481
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery

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.

Detailed description: Patient Blood Management (PBM) is an evidence based multidisciplinary approach for the care of patients who may need blood transfusion. The aim of PBM is achieving better patient outcomes by focusing on the patients' own blood as a source.

To date PBM is considered "good transfusion practice" and is being implemented in a growing number of countries. The Turkish Society of Anesthesiologists PBM Task Force is working on this subject since 4 years and decided to conduct a study. Before starting a PBM program, the transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and PBM strategies; the areas for improvement and the obstacles that could prevent change could be identified with this study. Data collection will also serve to identify the current situation as a reference and to control the achievement of the PBM's aim: improving clinical outcomes. These data will be refered as The Turkish National Perioperative Transfusion Study (TULIP TS) data.

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey.

The study evaluates i. The perioperative transfusion rates of RBCs, FFP and platelets. ii. With which reasons the anesthesiologists decide to transfuse a patient (co morbidities of the patients, physiologic transfusion triggers, hemoglobin trigger, uncontrolled bleeding, on request from surgeon etc.).

iii. The relation of transfusion and the patients co-morbidity index, the P POSSUM score and SORT score; anesthesia methods; monitorisation methods (hemodynamic, coagulation); amount of bleeding; type of surgery; type of hospital.

iv. The relation of transfusion and patient outcomes (unanticipated ICU admission, prolonged ICU stay, acute renal failure, thromboembolic events, ischemic events, pulmonary complications, cardiac advers events, infections, acute respiratory distress, infection, all-cause mortality).

Eligibility criteria: Inclusion Criteria:

Patients undergoing major elective surgery

Exclusion Criteria:

Trauma patients, emergency surgery

Primary outcomes:
measure: Preoperative amount of blood products transfused
timeFrame: Before surgery at day 0
measure: Intraoperative amount of blood products transfused
timeFrame: During surgery at day 0
measure: Postoperative amount of blood products transfused
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Preoperative transfusion indications
timeFrame: Before surgery at day 0
measure: Intraoperative transfusion indications
timeFrame: During surgery at day 1
measure: Postoperative transfusion indications
timeFrame: 24 hours after surgery
measure: Unanticipated ICU admission
timeFrame: After surgery at day 1
measure: Prolonged length of stay in ICU
timeFrame: After surgery at day 2
measure: Acute renal failure
timeFrame: After surgery at day 2
measure: Thromboembolic event
timeFrame: After surgery at day 2
measure: Ischemic event
timeFrame: After surgery at day 2
measure: Infection
timeFrame: After surgery at day 2
measure: Acute respiratory distress
timeFrame: After surgery at day 2
measure: Mortality
timeFrame: after surgery at day 30
measure: Preoperative anemia
timeFrame: Before surgery at day 0
measure: Preoperative coagulopathy
timeFrame: Before surgery at day 0
measure: Pretransfusion hemoglobin values
timeFrame: Before surgery at day 0
measure: Pretransfusion hemoglobin values
timeFrame: During surgery at day 1
measure: Pretransfusion hemoglobin values
timeFrame: After surgery at day 2
measure: Advers cardiac events
timeFrame: After surgery at day 30
Other outcomes:
Locations:
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: İstanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Training and Research 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: Kayseri
country: Turkey
facility: University of Health Sciences Kayseri Training and Research Hospital
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: Netherlands: Ministry of Health, Welfare and Sports
name: Dilek Unal, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
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