Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

NCT03891303 | Completed

• 1 other identifier: ABT2011-2016
• Study Type: observational
• Target: 426
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Transfusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Age as the predictor of higher ABT requirement

  Retrospective analysis, 6-year period

• Gender as the predictors 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

• Body surface area (BSA) 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

Study Arms (2)

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)

Non-transfused (non-TR)

Group received only autologous blood from intraoperative cell saver (ICS) during elective open abdominal aortic surgery.

Interventions

Allogenic blood transfusion (ABT) 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.

Transfused group (TR)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinic for Cardiovascular Diseases Magdalena: lead

Related Publications (4)

• 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.

  PMID: 20630687 BACKGROUND

• 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.

  PMID: 20802228 BACKGROUND

• 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.

  PMID: 24884605 BACKGROUND

• 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.

  PMID: 19111480 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 27, 2019
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: October 15, 2018
• Last Updated: March 29, 2019

Record last verified: 2019-03