Investigation of the Transfusion Practices in Surgical Patients in Turkey

Surgery Clinical Trial

— CeKATU  

Official title:

Investigation of the Transfusion Practices in Surgical Patients in Turkey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468738
• Other study ID #: Dilek Yazicioglu Unal
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2018
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6481
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients undergoing major elective surgery

Exclusion Criteria:

Trauma patients, emergency surgery

Related Conditions & MeSH terms

• Anemia
• Blood Coagulation Disorders
• Blood Loss Anemia
• Blood Loss, Surgical
• Blood Transfusion
• Coagulation Disorder
• Hemorrhage
• Hemostatic Disorders
• Surgery

Intervention

Other:
• Blood transfusion
Transfusion of blood products in the perioperative period in patients undergoing major surgery

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	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 Medeniyet University Goztepe Training and Research 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	University of Health Sciences Kayseri Training and Research Hospital	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 (2)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital	Turkish Society of Anesthesiology and Reanimation

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — 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/bja/aes135. — 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	Preoperative amount of blood products transfused	Preoperative amount of blood products: RBCs,FFP and platelets transfused	Before surgery at day 0
Primary	Intraoperative amount of blood products transfused	Intraoperative amount of blood products: RBC's,FFP and platelets transfused	During surgery at day 0
Primary	Postoperative amount of blood products transfused	Postoperative amount of blood products: RBCs,FFP and platelets transfused	24 hours after surgery
Secondary	Preoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	Before surgery at day 0
Secondary	Intraoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	During surgery at day 1
Secondary	Postoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	24 hours after surgery
Secondary	Unanticipated ICU admission	Whether the patient had an unanticipated ICU admission	After surgery at day 1
Secondary	Prolonged length of stay in ICU	Whether the patient had a prolonged length of stay in ICU	After surgery at day 2
Secondary	Acute renal failure	Whether the patient had acute renal failure	After surgery at day 2
Secondary	Thromboembolic event	Whether the patient had a thromboembolic event concerning lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or extremities etc.	After surgery at day 2
Secondary	Ischemic event	Whether the patient had an ischemic event concerning heart, nervous system,limb, gastrointestinal tract etc.	After surgery at day 2
Secondary	Infection	Whether the patient had infection: wound, pneumonia, urinary, sepsis etc.	After surgery at day 2
Secondary	Acute respiratory distress	Whether the patient had acute respiratory distress	After surgery at day 2
Secondary	Mortality	Whether the patient died: all cause mortality	after surgery at day 30
Secondary	Preoperative anemia	Whether the patient had anemia (Hemoglobin male < 13 female < 12 g/dL)	Before surgery at day 0
Secondary	Preoperative coagulopathy	Whether the patient had coagulopathy due to disease or drugs	Before surgery at day 0
Secondary	Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	Before surgery at day 0
Secondary	Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	During surgery at day 1
Secondary	Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	After surgery at day 2
Secondary	Advers cardiac events	Whether the patient had an advers cardiac event: myocardial infaction; non fatal cardiac arest; arrhytmia; cardiogenic pulmonary edema etc	After surgery at day 30