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Clinical Trials/NCT03891303
NCT03891303
Completed
Not Applicable

Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery and Its Predictors: a Retrospective Database Study at a Tertiary Hospital in Croatia

Clinic for Cardiovascular Diseases Magdalena0 sites426 target enrollmentJanuary 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Transfusion
Sponsor
Clinic for Cardiovascular Diseases Magdalena
Enrollment
426
Primary Endpoint
Overall ABT requirement
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Open surgery on the abdominal aorta is a high risk procedure associated with an intravascular volume blood loss and thereby, with high requirement for blood and blood product transfusion.

The aim of this study was to establish the rate for allogenic blood transfusion (ABT) during elective open abdominal aortic surgery and find parameters associated with ABT requirements.

Detailed Description

Two distinct clinical entities affect the abdominal aorta: abdominal aortic aneurysm (AAA) and aortoiliac occlusive disease (AIOD). These are multifactorial vascular disorders caused by complex genetic and environmental factors. Older patients with more comorbidity are often affected. Open abdominal aortic surgery is associated with high mortality rate. Even in specialised institutions it varies from 2 to 5%. Similar results can be compared to mortality for coronary artery bypass grafting. This reflects the complexity of the surgery and the general health of those patients. It is associated with intravascular volume blood loss and, thereby, with a high requirement for blood and blood products transfusion. Allogenic blood transfusion (ABT) has been associated with an increased risk of tumour recurrence, postoperative infection, acute lung injury, perioperative myocardial infarction, postoperative low-output cardiac failure, and increased mortality. In the last decades, multiple strategies have been undertaken to prevent massive intraoperative blood loss during elective surgery and allogenic blood transfusion requirement. One of the method advocates a preoperative increase in red blood cells level using B12, folic acid and iron supplements or with erythropoietin usage. Other methods involve the optimisation of surgical technique and the use of a machine for intraoperative blood salvage, known as "cell saver". The aim of this study was to establish the rate for ABT during elective open abdominal aortic surgery, find parameters associated with ABT requirements, and optimise the investigators hospital's maximum surgical blood ordering schedule (MSBOS).

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
October 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinic for Cardiovascular Diseases Magdalena
Responsible Party
Principal Investigator
Principal Investigator

Katarina Tomulic Brusich

Principal Investigator

Clinic for Cardiovascular Diseases Magdalena

Eligibility Criteria

Inclusion Criteria

  • Patients older than 18 years
  • Elective open abdominal aortic surgery
  • Abdominal aortic aneurysm repair
  • Abdominal aortic bypass grafting for occlusive aortoiliac disease

Exclusion Criteria

  • Patients younger than 18 years
  • Patients undergoing cardiac surgery
  • Patients with ruptured abdominal aneurysms
  • Patients undergoing endovascular aortic repair
  • Patients submitted to other types of vascular surgery (i.e., carotid endarterectomy or peripheral bypass surgery)

Outcomes

Primary Outcomes

Overall ABT requirement

Time Frame: Retrospective analysis, 6-year period

Overall ABT requirement (in %) during elective abdominal aortic surgery with the use of ICS for intraoperative blood salvage and autologous transfusion.

Secondary Outcomes

  • Gender as the predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Total blood volume as the possible predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Length of stay (LOS)(Retrospective analysis, 6-year period)
  • In-hospital mortality rate(Retrospective analysis, 6-year period)
  • Age as the predictor of higher ABT requirement(Retrospective analysis, 6-year period)
  • Body mass index (BMI) as the predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Type of illness as the predictor of higher ABT requirement(Retrospective analysis, 6-year period)
  • Patient's comorbidities as the predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Body surface area (BSA) as the predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Hemoglobin (Hb) and hematocrit (Htc) as the predictors of higher ABT requirement(Retrospective analysis, 6-year period)
  • Medications that impair coagulation and homeostasis as the predictor of higher ABT requirement(Retrospective analysis, 6-year period)
  • Postoperative duration of mechanical ventilation(Retrospective analysis, 6-year period)

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