Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion
• Intervention / Treatment: Other: Allogenic blood transfusion (ABT)

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 Type: Observational
• Enrollment (Actual): 426

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A retrospective cross-sectional study was conducted using an existing computerised medical records database at the Department of Anaesthesiology and Intensive Care at the Clinic for Cardiovascular Diseases Magdalena. This Clinic is a tertiary hospital in Croatia specialised in cardiac and vascular surgery. This study is a retrospective analysis of consecutive patients undergoing elective major vascular surgery who had been prospectively risk-stratified.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transfused group (TR); Group received allogenic blood transfusion (ABT) alongside with autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.	Other: Allogenic blood transfusion (ABT); During elective open aortic surgery, the autologous blood from ICS was processed and re-transfused in all patients. However, TR group additionally received ABT.
Non-transfused (non-TR); Group received only autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall ABT requirement	Overall ABT requirement (in %) during elective abdominal aortic surgery with the use of ICS for intraoperative blood salvage and autologous transfusion.	Retrospective analysis, 6-year period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinic for Cardiovascular Diseases Magdalena

Publications and helpful links

General Publications

• Kent KC, Zwolak RM, Egorova NN, Riles TS, Manganaro A, Moskowitz AJ, Gelijns AC, Greco G. Analysis of risk factors for abdominal aortic aneurysm in a cohort of more than 3 million individuals. J Vasc Surg. 2010 Sep;52(3):539-48. doi: 10.1016/j.jvs.2010.05.090. Epub 2010 Jul 13.
• Ashworth A, Klein AA. Cell salvage as part of a blood conservation strategy in anaesthesia. Br J Anaesth. 2010 Oct;105(4):401-16. doi: 10.1093/bja/aeq244. Epub 2010 Aug 28.
• Roubinian NH, Murphy EL, Swain BE, Gardner MN, Liu V, Escobar GJ; NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III); Northern California Kaiser Permanente DOR Systems Research Initiative. Predicting red blood cell transfusion in hospitalized patients: role of hemoglobin level, comorbidities, and illness severity. BMC Health Serv Res. 2014 May 10;14:213. doi: 10.1186/1472-6963-14-213.
• Bursi F, Barbieri A, Politi L, Di Girolamo A, Malagoli A, Grimaldi T, Rumolo A, Busani S, Girardis M, Jaffe AS, Modena MG. Perioperative red blood cell transfusion and outcome in stable patients after elective major vascular surgery. Eur J Vasc Endovasc Surg. 2009 Mar;37(3):311-8. doi: 10.1016/j.ejvs.2008.12.002. Epub 2008 Dec 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): October 15, 2018

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 23, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Aorta, abdominal; Intraoperative blood salvage; Elective surgical procedures; Patient outcomes assessment
• Other Study ID Numbers: ABT2011-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No