Restrictive Versus Liberal Transfusion, Major Surgeries

Study Overview
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Brief Summary
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Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.

Detailed Description
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The test subjects consisted of 892 patients, who belong to ASA (American society of Anesthesiology) I -IV groups, underwent elective major surgery between the 01/01/2016-31/12/2016, and are over the age of 18 years. The demographic data (Age, sex, ASA (American society of Anesthesiology) scors, surgery type) were also recorded. we evaluated the value of Hemoglobin, platelet, APTT (activated partial thromboplastin time), INR (international normalized ratio) preoperatively and postoperatively. In this study, restrictive and liberal blood transfusion groups were investigated.restrictive and liberal transfusion hemoglobin threshold value respectively before perioperative transfusion was 8 g / dL. were defined as restrictive blood transfusion group and perioperative transfusion was over 8 g / dL were defined as liberal blood transfusion group. Adverse events (tachycardia, hypotension, the value of lactate and metabolic acidosis). Postoperatively, the amount of postoperative transfusion unit, duration of hospital stay, requirement of intensive care unit and mortality rate.

Official Title
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Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion

Conditions
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Transfusion Related Complication

Intervention / Treatment
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* Other: restrictive and liberal transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old patients, ASA I-II-III-IV, Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery) Exclusion Criteria: Emergency operation, Cardiovascular surgery, ASA V-VI Under 18 years old patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transfusion<br>Patients (n:892) were enrolled who underwent elective major surgery between the 01/01/2016-31/12/2016, and over the age of 18 years. They separated subgroups as restrictive and liberal blood transfusion groups | Other: restrictive and liberal transfusion<br>* hemoglobin threshold value was accepted 8g/dl. restrictive blood transfusion group was defined that if perioperative transfusion was started equal or under hemoglobin level 8 g / dL. Liberal blood transfusion group was defined as perioperative transfusion was started over hemoglobin level 8 g / dL .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restrictive or Liberal transfusion | It is determined how many units of RBC (red blood cell ) used during major operations at the hospital in liberal transfusion group or restrictive transfusion group. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Survival ratios between the restrictive transfusion group and the liberal transfusion group are compared. | 52 weeks | 
| Postoperative transfusion requirement | The requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined. | 52 Weeks | 
| The Need of ICU | The need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined. | 52 Weeks | 
| Postoperative Duration of Stay in Hospital of patients | The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared. | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion, liberal, restrictive