Restrictive Versus Liberal Transfusion, Major Surgeries

NCT03394274 | Completed

• 1 other identifier: 814
• Study Type: observational
• Target: 892
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion Related Complication

Keywords

transfusion; liberal; restrictive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality

  52 weeks

• Postoperative transfusion requirement

  52 Weeks

• The Need of ICU

  52 Weeks

• Postoperative Duration of Stay in Hospital of patients

  52 Weeks

Study Arms (1)

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

Interventions

restrictive and liberal transfusion OTHER

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 .

Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Over 18 years old patients,
• ASA I-II-III-IV,
• Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)

You may not qualify if:

• Emergency operation,
• Cardiovascular surgery,
• ASA V-VI
• Under 18 years old patients

Sponsors & Collaborators

• Leyla Kılınc: lead

Study Sites (1)

University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 26787795 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor, anesthesiology specialist

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: January 9, 2018
• Study Start: June 14, 2017
• Primary Completion: September 15, 2017
• Study Completion: November 15, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)