Investigation of the Transfusion Practices in Surgical Patients in Turkey

Completed

• Conditions: Blood Loss, Surgical; Coagulation Disorder; Anemia; Blood Loss Anemia; Blood Transfusion; Surgery

• Registration Number: NCT03468738
• Lead Sponsor: Diskapi Teaching and Research Hospital

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).

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-11
• Study First Posted: 2018-03-19
• Status Verified: 2018-04
• Study Start: 2018-04-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6481

Inclusion Criteria

Patients undergoing major elective surgery

Exclusion Criteria

Trauma patients, emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preoperative amount of blood products transfused	Before surgery at day 0	Preoperative amount of blood products: RBCs,FFP and platelets transfused
Intraoperative amount of blood products transfused	During surgery at day 0	Intraoperative amount of blood products: RBC's,FFP and platelets transfused
Postoperative amount of blood products transfused	24 hours after surgery	Postoperative amount of blood products: RBCs,FFP and platelets transfused

Secondary Outcome Measures

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

Trial Locations

Locations (61)

Acibadem University Mehmet Ali Aydinlar Atakent Hospital; 🇹🇷 Ankara, Turkey

Ankara University Cebeci Medical Center; 🇹🇷 Ankara, Turkey

Ankara University Ibni Sina Hospital; 🇹🇷 Ankara, Turkey

Başkent 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

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