Restrictive Versus Liberal Transfusion, Major Surgeries

Transfusion Related Complication Clinical Trial

— transfusion  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394274
• Other study ID #: 814
• Status: Completed
• Phase: N/A
• First received: November 27, 2017
• Last updated: January 10, 2018
• Start date: June 14, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: January 2018
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 892
• Est. completion date: November 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transfusion Related Complication

Intervention

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 .

Locations

Country	Name	City	State
Turkey	University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Leyla Kilinc

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Survival ratios between the restrictive transfusion group and the liberal transfusion group are compared.	52 weeks
Secondary	Postoperative transfusion requirement	The requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined.	52 Weeks
Secondary	The Need of ICU	The need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined.	52 Weeks
Secondary	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