Investigation of the Transfusion Practices in Surgical Patients in Turkey

NCT ID: NCT03468738

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6481 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-02-01

Brief Summary

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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

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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).

Conditions

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Surgery Blood Loss, Surgical Blood Loss Anemia Blood Transfusion Anemia Coagulation Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Blood transfusion

Transfusion of blood products in the perioperative period in patients undergoing major surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients undergoing major elective surgery

Exclusion Criteria

Trauma patients, emergency surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Anesthesiology and Reanimation

OTHER

Sponsor Role collaborator

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Unal, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Netherlands: Ministry of Health, Welfare and Sports

Locations

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Acibadem University Mehmet Ali Aydinlar Atakent Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ankara University Cebeci Medical Center

Ankara, , Turkey (Türkiye)

Site Status

Ankara University Ibni Sina Hospital

Ankara, , Turkey (Türkiye)

Site Status

Başkent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Private Cankaya Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ufuk University Medical Faculty Dr. Ridvan Ege Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health sciences Ankara Child Health and Diseases Hematology Oncology Training and research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Ankara Numune Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Diskapi Yildirim Beyazit Trainig Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Dr Abdurrahman Yurtaslanı Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Kecioren Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Turkiye Yuksek Ihtisas Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Yenimahalle Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences Zubeyde Hanim Gynecology and Maternity Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

University of Technology and Economics Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz University Medical Faculty

Antalya, , Turkey (Türkiye)

Site Status

University of Health Sciences Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Balikesir University Training and Research Hospital

Balıkesir, , Turkey (Türkiye)

Site Status

Uludağ University Medical Faculty

Bursa, , Turkey (Türkiye)

Site Status

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Hitit University Corum Erol Olcok Training and Research Hospital

Çorum, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Fırat University Medical Faculty

Elâzığ, , Turkey (Türkiye)

Site Status

Erzincan University Mengucek Gazi Training and Research Hospital

Erzincan, , Turkey (Türkiye)

Site Status

Eskisehir Osmangazi University Medical Faculty

Eskişehir, , Turkey (Türkiye)

Site Status

Suleyman Demirel University Medical Faculty

Isparta, , Turkey (Türkiye)

Site Status

Acibadem University Altunizade Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Haydarpasa Numne Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Istanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Okmeydanı Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

University of Health Sciences Umraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Dokuz Eylul University Medical Faculty

Izmir, , Turkey (Türkiye)

Site Status

University of Health Sciences Bozyaka Training Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

University of Health Sciences İzmir Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Sutcu Imam University Medical Faculty

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Erciyes University Medical Faculty

Kayseri, , Turkey (Türkiye)

Site Status

University of Health Sciences Kayseri Training and Research Hospital

Kayseri, , Turkey (Türkiye)

Site Status

Anadolu Health Center Hospital

Kocaeli, , Turkey (Türkiye)

Site Status

University of Health Sciences Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

Site Status

Necmettin Erbakan University Meram Medical Faculty Center for Health and Research

Konya, , Turkey (Türkiye)

Site Status

Selcuk University Medical Faculty

Konya, , Turkey (Türkiye)

Site Status

University of Health Sciences Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Site Status

Inonu University Liver Transplantation Institute

Malatya, , Turkey (Türkiye)

Site Status

Manisa Celal Bayar University Medical Faculty Hafsa Sultan Hospital

Manisa, , Turkey (Türkiye)

Site Status

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Site Status

Ordu University Medical Faculty

Ordu, , Turkey (Türkiye)

Site Status

Osmaniye State Hospital

Osmaniye, , Turkey (Türkiye)

Site Status

Ondokuz Mayıs University Medical Faculty

Samsun, , Turkey (Türkiye)

Site Status

Namık Kemal University Medical Faculty

Tekirdağ, , Turkey (Türkiye)

Site Status

Karadeniz Technical University Medical Faculty Farabi Hospital

Trabzon, , Turkey (Türkiye)

Site Status

Tunceli State Hospital

Tunceli, , Turkey (Türkiye)

Site Status

Van Yuzuncuyıl University Medical Faculty Dursun Odabası Center

Van, , Turkey (Türkiye)

Site Status

Bulent Ecevit University Medical Faculty Center for Health and Research

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22593128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26787795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17998460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9699234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20642690 (View on PubMed)

Other Identifiers

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Dilek Yazıcıoglu Unal

Identifier Type: -

Identifier Source: org_study_id

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