Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

Completed

• Conditions: Blood Transfusion
• Interventions: Other: Allogenic blood transfusion (ABT)

• Registration Number: NCT03891303
• Lead Sponsor: Clinic for Cardiovascular Diseases Magdalena

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).

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-10-15
• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-23
• Study First Posted: 2019-03-27
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfused group (TR)	Allogenic blood transfusion (ABT)	Group received allogenic blood transfusion (ABT) alongside with autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.

Primary Outcome Measures

Name	Time	Method
Overall ABT requirement	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 Outcome Measures

Name	Time	Method
Gender as the predictors of higher ABT requirement	Retrospective analysis, 6-year period	male/female
Total blood volume as the possible predictors of higher ABT requirement	Retrospective analysis, 6-year period	TBV (in liters) calculated trough Nadler's formula
Length of stay (LOS)	Retrospective analysis, 6-year period	LOS in ICU (days) and overall hospital LOS (days)
In-hospital mortality rate	Retrospective analysis, 6-year period	(in %)
Age as the predictor of higher ABT requirement	Retrospective analysis, 6-year period	(years)
Body mass index (BMI) as the predictors of higher ABT requirement	Retrospective analysis, 6-year period	BMI (kg/m2)
Type of illness as the predictor of higher ABT requirement	Retrospective analysis, 6-year period	abdominal aortic aneurysm or aortoiliac occlusive disease
Patient's comorbidities as the predictors of higher ABT requirement	Retrospective analysis, 6-year period	arterial hypertension, coronary artery disease, diabetes, atrial fibrillation, cerebrovascular incidents, chronic obstructive pulmonary disease, chronic renal insufficiency, malignancy
Body surface area (BSA) as the predictors of higher ABT requirement	Retrospective analysis, 6-year period	BSA (m²)
Hemoglobin (Hb) and hematocrit (Htc) as the predictors of higher ABT requirement	Retrospective analysis, 6-year period	Hb (g/L) and Htc (%)
Medications that impair coagulation and homeostasis as the predictor of higher ABT requirement	Retrospective analysis, 6-year period	acetylsalicylic acid, clopidogrel, or warfarin
Postoperative duration of mechanical ventilation	Retrospective analysis, 6-year period	(hours)