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Completed

NCT Number: NCT03468738

Investigation of the Transfusion Practices in Surgical Patients in Turkey

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.

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Key information

Conditions

Surgery Anemia Blood Loss Anemia Blood Loss, Surgical Blood Transfusion Cardiovascular Diseases Coagulation Disorder Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Acibadem University Mehmet Ali Aydinlar Atakent Hospital, Ankara, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing major elective surgery

Exclusion criteria

Trauma patients, emergency surgery

Treatment and study plan

Blood transfusion

Other

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

Primary outcomes

  1. Preoperative amount of blood products transfused

    Time frame: Before surgery at day 0

    Preoperative amount of blood products: RBCs,FFP and platelets transfused

  2. Intraoperative amount of blood products transfused

    Time frame: During surgery at day 0

    Intraoperative amount of blood products: RBC's,FFP and platelets transfused

  3. Postoperative amount of blood products transfused

    Time frame: 24 hours after surgery

    Postoperative amount of blood products: RBCs,FFP and platelets transfused

Secondary outcomes

  1. Preoperative transfusion indications

    Time frame: Before surgery at day 0

    The reasons to decide to transfuse (factors determining transfusion) blood products

  2. Intraoperative transfusion indications

    Time frame: During surgery at day 1

    The reasons to decide to transfuse (factors determining transfusion) blood products

  3. Postoperative transfusion indications

    Time frame: 24 hours after surgery

    The reasons to decide to transfuse (factors determining transfusion) blood products

  4. Unanticipated ICU admission

    Time frame: After surgery at day 1

    Whether the patient had an unanticipated ICU admission

  5. Prolonged length of stay in ICU

    Time frame: After surgery at day 2

    Whether the patient had a prolonged length of stay in ICU

  6. Acute renal failure

    Time frame: After surgery at day 2

    Whether the patient had acute renal failure

  7. Thromboembolic event

    Time frame: After surgery at day 2

    Whether the patient had a thromboembolic event concerning lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or extremities etc.

  8. Ischemic event

    Time frame: After surgery at day 2

    Whether the patient had an ischemic event concerning heart, nervous system,limb, gastrointestinal tract etc.

  9. Infection

    Time frame: After surgery at day 2

    Whether the patient had infection: wound, pneumonia, urinary, sepsis etc.

  10. Acute respiratory distress

    Time frame: After surgery at day 2

    Whether the patient had acute respiratory distress

  11. Mortality

    Time frame: after surgery at day 30

    Whether the patient died: all cause mortality

  12. Preoperative anemia

    Time frame: Before surgery at day 0

    Whether the patient had anemia (Hemoglobin male < 13 female < 12 g/dL)

  13. Preoperative coagulopathy

    Time frame: Before surgery at day 0

    Whether the patient had coagulopathy due to disease or drugs

  14. Pretransfusion hemoglobin values

    Time frame: Before surgery at day 0

    The hemoglobin concentration before transfusion

  15. Pretransfusion hemoglobin values

    Time frame: During surgery at day 1

    The hemoglobin concentration before transfusion

  16. Pretransfusion hemoglobin values

    Time frame: After surgery at day 2

    The hemoglobin concentration before transfusion

  17. Advers cardiac events

    Time frame: After surgery at day 30

    Whether the patient had an advers cardiac event: myocardial infaction; non fatal cardiac arest; arrhytmia; cardiogenic pulmonary edema etc

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Collaborators

  • Turkish Society of Anesthesiology and Reanimation

Registry information

Acronym: CeKATU

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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