Investigation of the Transfusion Practices in Surgical Patients in Turkey (CeKATU)

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Surgery; Coagulation Disorder; Blood Loss, Surgical; Blood Transfusion; Blood Loss Anemia
• Intervention / Treatment: Other: Blood transfusion

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).

• Study Type: Observational
• Enrollment (Actual): 6481

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University Medical Faculty
  • Ankara, Turkey
    • Hacettepe University Medical Faculty
  • Ankara, Turkey
    • Ankara University Ibni Sina Hospital
  • Ankara, Turkey
    • Baskent University Ankara Hospital
  • Ankara, Turkey
    • Acibadem University Mehmet Ali Aydinlar Atakent Hospital
  • Ankara, Turkey
    • Ankara University Cebeci Medical Center
  • 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 Yurtaslanı 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
  • Antalya, Turkey
    • Akdeniz University Medical Faculty
  • Antalya, Turkey
    • University of Health Sciences Antalya Training and Research Hospital
  • Balıkesir, Turkey
    • Balikesir University Training and Research Hospital
  • Bursa, Turkey
    • Uludag University Medical Faculty
  • Bursa, Turkey
    • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
  • Edirne, Turkey
    • Trakya University Medical Faculty
  • Elazığ, Turkey
    • Fırat University Medical Faculty
  • Erzincan, Turkey
    • Erzincan University Mengucek Gazi Training and Research Hospital
  • Eskişehir, Turkey
    • Eskisehir Osmangazi University Medical Faculty
  • Isparta, Turkey
    • Suleyman Demirel University Medical Faculty
  • Istanbul, Turkey
    • Istanbul University Medical Faculty
  • Istanbul, Turkey
    • Marmara University Pendik Training and Research Hospital
  • Istanbul, Turkey
    • Acibadem University Altunizade 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 Okmeydanı Training and Research Hospital
  • Istanbul, Turkey
    • University of Health Sciences Umraniye Training and Research Hospital
  • Kahramanmaraş, Turkey
    • Sutcu Imam University Medical Faculty
  • Kayseri, Turkey
    • Erciyes University Medical Faculty
  • Kayseri, Turkey
    • University of Health Sciences Kayseri Training and Research Hospital
  • Kocaeli, Turkey
    • Anadolu Health Center Hospital
  • Kocaeli, Turkey
    • University of Health Sciences Derince Training and Research Hospital
  • Konya, Turkey
    • Selcuk University Medical Faculty
  • Konya, Turkey
    • Necmettin Erbakan University Meram Medical Faculty Center for Health and Research
  • Konya, Turkey
    • University of Health Sciences Konya Training and Research Hospital
  • Malatya, Turkey
    • Inonu University Liver Transplantation Institute
  • Manisa, Turkey
    • Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital
  • Mersin, Turkey
    • Mersin University Medical Faculty
  • Ordu, Turkey
    • Ordu University Medical Faculty
  • Osmaniye, Turkey
    • Osmaniye State Hospital
  • Samsun, Turkey
    • Ondokuz Mayıs University Medical Faculty
  • Tekirdağ, Turkey
    • Namık Kemal University Medical Faculty
  • Trabzon, Turkey
    • Karadeniz Technical University Medical Faculty Farabi Hospital
  • Tunceli, Turkey
    • Tunceli State Hospital
  • Van, Turkey
    • Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center
  • Zonguldak, Turkey
    • Bulent Ecevit University Medical Faculty Center for Health and Research
  • Çorum, Turkey
    • Hitit University Corum Erol Olcok Training and Research Hospital
  • İstanbul, Turkey
    • Istanbul Medeniyet University Goztepe Training and Research Hospital
  • İzmir, Turkey
    • Dokuz Eylul University Medical Faculty
  • İzmir, Turkey
    • University of Health Sciences Bozyaka Training Research Hospital
  • İzmir, Turkey
    • University of Health Sciences Izmir Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing major elective surgery in General surgery Orthopedics Urology Transplantation surgery Neurosurgery Gynecology and obstetrics Cardiovascular surgery

Description

Inclusion Criteria:

Patients undergoing major elective surgery

Exclusion Criteria:

Trauma patients, emergency surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	Before surgery at day 0
Intraoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	During surgery at day 1
Postoperative transfusion indications	The reasons to decide to transfuse (factors determining transfusion) blood products	24 hours after surgery
Unanticipated ICU admission	Whether the patient had an unanticipated ICU admission	After surgery at day 1
Prolonged length of stay in ICU	Whether the patient had a prolonged length of stay in ICU	After surgery at day 2
Acute renal failure	Whether the patient had acute renal failure	After surgery at day 2
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
Ischemic event	Whether the patient had an ischemic event concerning heart, nervous system,limb, gastrointestinal tract etc.	After surgery at day 2
Infection	Whether the patient had infection: wound, pneumonia, urinary, sepsis etc.	After surgery at day 2
Acute respiratory distress	Whether the patient had acute respiratory distress	After surgery at day 2
Mortality	Whether the patient died: all cause mortality	after surgery at day 30
Preoperative anemia	Whether the patient had anemia (Hemoglobin male < 13 female < 12 g/dL)	Before surgery at day 0
Preoperative coagulopathy	Whether the patient had coagulopathy due to disease or drugs	Before surgery at day 0
Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	Before surgery at day 0
Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	During surgery at day 1
Pretransfusion hemoglobin values	The hemoglobin concentration before transfusion	After surgery at day 2
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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Collaborators: Turkish Society of Anesthesiology and Reanimation
• Investigators: Principal Investigator: Dilek Unal, Assoc Prof, Netherlands: Ministry of Health, Welfare and Sports

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 11, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Intraoperative Complications; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Anemia; Blood Loss, Surgical
• Other Study ID Numbers: Dilek Yazıcıoglu Unal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No