Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

Blood Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891303
• Other study ID #: ABT2011-2016
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: October 15, 2018

Study information

• Verified date: March 2019
• Source: Clinic for Cardiovascular Diseases Magdalena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: October 15, 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Transfusion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinic for Cardiovascular Diseases Magdalena

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age as the predictor of higher ABT requirement	(years)	Retrospective analysis, 6-year period
Secondary	Gender as the predictors of higher ABT requirement	male/female	Retrospective analysis, 6-year period
Secondary	Body mass index (BMI) as the predictors of higher ABT requirement	BMI (kg/m2)	Retrospective analysis, 6-year period
Secondary	Body surface area (BSA) as the predictors of higher ABT requirement	BSA (m²)	Retrospective analysis, 6-year period
Secondary	Total blood volume as the possible predictors of higher ABT requirement	TBV (in liters) calculated trough Nadler's formula	Retrospective analysis, 6-year period
Secondary	Hemoglobin (Hb) and hematocrit (Htc) as the predictors of higher ABT requirement	Hb (g/L) and Htc (%)	Retrospective analysis, 6-year period
Secondary	Type of illness as the predictor of higher ABT requirement	abdominal aortic aneurysm or aortoiliac occlusive disease	Retrospective analysis, 6-year period
Secondary	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
Secondary	Medications that impair coagulation and homeostasis as the predictor of higher ABT requirement	acetylsalicylic acid, clopidogrel, or warfarin	Retrospective analysis, 6-year period
Secondary	Postoperative duration of mechanical ventilation	(hours)	Retrospective analysis, 6-year period
Secondary	Length of stay (LOS)	LOS in ICU (days) and overall hospital LOS (days)	Retrospective analysis, 6-year period
Secondary	In-hospital mortality rate	(in %)	Retrospective analysis, 6-year period