Restrictive Versus Liberal Transfusion, Major Surgeries (transfusion)

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

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.

Study Overview

• Status: Completed
• Conditions: Transfusion Related Complication
• Intervention / Treatment: Other: restrictive and liberal transfusion

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 Type: Observational
• Enrollment (Actual): 892

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Over 18 years old patients, ASA I-II-III-IV, major surgeries ( Intraabdominal, intracranial, head and neck malignanacy surgery, femur and vertebra surgery) were enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: restrictive and liberal transfusion; 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 .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Leyla Kılınc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: transfusion; restrictive; liberal
• Other Study ID Numbers: 814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No