Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

NCT ID: NCT03891303

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 426 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2018-10-15

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).

Conditions

Blood Transfusion

Keywords

Aorta, abdominal; Intraoperative blood salvage; Elective surgical procedures; Patient outcomes assessment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Transfused group (TR)

Group received allogenic blood transfusion (ABT) alongside with autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.

Allogenic blood transfusion (ABT)

Intervention Type: OTHER

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinic for Cardiovascular Diseases Magdalena

NETWORK

Sponsor Role: lead

Responsible Party

Katarina Tomulic Brusich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 20630687 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20802228 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24884605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19111480 (View on PubMed)

Other Identifiers

ABT2011-2016

Identifier Type: -

Identifier Source: org_study_id