Restrictive Versus Liberal Transfusion, Major Surgeries

Completed

• Conditions: Transfusion Related Complication
• Interventions: Other: restrictive and liberal transfusion

• Registration Number: NCT03394274
• Lead Sponsor: Leyla Kılınc

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-14
• Primary Completion: 2017-09-15
• Study Completion: 2017-11-15
• Study First Submitted: 2017-11-27
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-06
• Study First Posted: 2018-01-09
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 892

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfusion	restrictive and liberal transfusion	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

Primary Outcome Measures

Name	Time	Method
Restrictive or Liberal transfusion	52 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey