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Clinical Trials/NCT03394274
NCT03394274
Completed
Not Applicable

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

Leyla Kılınc1 site in 1 country892 target enrollmentJune 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transfusion Related Complication
Sponsor
Leyla Kılınc
Enrollment
892
Locations
1
Primary Endpoint
Restrictive or Liberal transfusion
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2017
End Date
November 15, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Leyla Kılınc
Responsible Party
Sponsor Investigator
Principal Investigator

Leyla Kılınc

medical doctor, anesthesiology specialist

Sisli Hamidiye Etfal Training and Research Hospital

Eligibility Criteria

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,
  • Under 18 years old patients

Outcomes

Primary Outcomes

Restrictive or Liberal transfusion

Time Frame: 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 Outcomes

  • Postoperative transfusion requirement(52 Weeks)
  • Postoperative Duration of Stay in Hospital of patients(52 Weeks)
  • Mortality(52 weeks)
  • The Need of ICU(52 Weeks)

Study Sites (1)

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