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ORIGINAL CONTRIBUTIONS

Received: March 14^th 2014

Accepted: March 11^th 2015

Perioperative risk factors associated with allogeneic blood transfusion in patients with hip fracture surgery

Jaime Jesús Durán-Nah,^a Sofía Elisa Pastelín-Ruiz,^b Emilio de Jesús Miam-Viana^c

^aCoordinación Clínica, Hospital General Regional 12, Mérida, Yucatán.

^bServicio de Cirugía Articular Reconstructiva, Hospital de Ortopedia “Victorio de la Fuente Narváez”, Distrito Federal

^cServicio de Ortopedia, Hospital General Regional 1, Mérida, Yucatán

Instituto Mexicano del Seguro Social, México

Communication with: Jaime Jesús Durán-Nah

Telephone: (999) 925 8910

Email: durannah@prodigy.net.mx, jdurannah@gmail.com

Background: The aim of this article is to identify risk factors associated with allogeneic blood transfusion (ABT) in patients undergoing hip surgery during 2008–2009, at a General Hospital, in Yucatán, Mexico.

Methods: Data of patients who received at least one package of allogeneic blood either before, during, or after hip surgery, (cases, n = 118), was compared against that of patients having the same type of surgery, but not transfused with an ABT (controls, n =138). Logistic regression analysis was carried on in estimating associations. Odd Ratios (OR) and 95 % confidence intervals (95 % CI), were applied when appropriate.

Results: Bleeding ≥ 400 ml during surgery (vs < 400 ml, OR 5.68, 95% CI 2.5–12.9, p = 0.007), and having pre surgical hemoglobin (Hb) concentration < 11 g/dL (vs ≥ 11 g/dL, OR 2.86, 95% CI 1.5–5.6; p = 0.001)” were both, associated with ABT. Duration of surgery, the femoral segment involved, the surgical procedure and the postsurgical Hb, were all excluded.

Conclusions: Bleeding ≥ 400 ml during surgery and having pre surgical Hb concentration < 11 g/dL were both, associated with increased risk of receiving an ABT.

Keywords: Hip fractures; Blood transfusion; Risk factors

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The decision to give blood transfusion to the patient scheduled for surgery patient has not been free from criticism in favor^1,2 or against, especially when the morbidity and mortality associated with allogeneic blood transfusion is analyzed,^3-6 aspects that partly explain the variable prevalence of their use in the surgical setting. Browne et al,⁶ citing data from the University Hospital Consortium, said that in hip arthroplasty between 5% and 80% receive blood transfusion; Friedman et al.5 document up to 70% of patients with the same type of surgery or knee surgery; Newman et al.⁷ reported use up to 52.1%, either allogeneic or autologous, while according to Hart et al.⁴ up to 22% of those requiring total hip arthroplasty received blood transfusion, a frequency reduced to 18% when the surgery is knee arthroplasty.

Various factors have been associated with medical decision to give blood transfusion with allogeneic blood to the patient who undergoes hip surgery, with commonalities and differences between the results.^4,6,8-10 Hart et al.⁴ report that preoperative anemia is the factor that increases the risk 3.6 times, female gender increases it 2 times, body mass index 1.4 times, and categories 3 or 4 of the physical state classification system of the American Society of Anesthesiologists up to 1.3 times. Browne et al.6 also identify preoperative anemia, female gender, age >80 years and having at least one chronic condition, as major risk factors.

In cases of fast track hip or knee surgery Jans et al.⁸ also note that preoperative anemia is the factor that increased the risk up to 4.7 times, while in Gul et al.⁹ preoperative hemoglobin level (Hb) (11 g/dL) and the type of fracture are identified as variables associated with postoperative blood transfusion, overruling age and gender as such. Rashiq et al.¹⁰ indicate that female gender increases the risk 1.73 times, and age 65 and up increases it gradually, upping the level of risk 1.8 fold in patients 65 to 69 years, and 2.74 times in the group aged 80 years or more; while preoperative Hb <12 g/dL increases risk 13.8 times, having > 14 g/dL increases it 3.48 times and the type of surgery 2.45 times, especially when the type is revision.

Given the variability of the data and with the intention of making these known, this research raised as its main objective to identify risk factors before and during surgery associated with allogeneic blood transfusion in patients with hip surgery performed in an urban general hospital of the Mexican Institute Social Security (IMSS) in Merida, Yucatan, Mexico.

Methods

A prevalent case-control method was used which included primary hip surgery patients due to fracture of diverse etiology between January 2008 and December 2009, patients who were identified from the diagnosis discharge list in the clinical files of IMSS Regional General Hospital 1. The sample size was decided non-probabilistically, the only criterion being that patients have been operated during the period cited above, and consecutively selected for convenience. The data were taken from medical records, either hospital outcome notes, surgical sheet or anesthesia sheet. To remedy the lack of some relevant data such as the definition of pre and postoperative anemia and abnormal trans-surgical bleeding, the researchers turned to the group consensus, supported by references.

The cases included patients of either gender ≥ 50 years of age, with or without chronic disease who have received at the direction of orthopedic doctor or the anesthesiologist responsible for the surgery at least one unit of allogeneic blood. Patients were excluded whose surgery was performed in a different hospital than the study headquarters, as were those surgically treated for reason other than fracture or for revision of a previous surgery. As controls we included patients who met the same inclusion criteria of cases, but that were not given blood transfusion during the period mentioned. Exclusion criteria were the same as those applied to cases.

The variables analyzed were: age, gender, comorbidity, number of comorbid conditions, preoperative and postoperative Hb concentration, duration of surgery, intervened cervicofemoral segment, trans-surgical procedure performed, and bleeding. Comorbidity was defined as the presence of any chronic disease of at least six months duration prior to surgery, as reported by the patient, and included diabetes mellitus, and hypertension or heart disease, among others. Preoperative Hb concentration was defined as the g/dL reported by the clinical laboratory of the hospital from a blood sample taken at the time of patient admission or during their first 24 hours of hospitalization. As clinical record does not capture medical or surgical argument for or against blood transfusion, for the purposes of the investigation it was decided to consider the Hb ≥ 11 g/dL as the cutoff or criterion for not doing so, and <11 g/dL as the criterion for doing so, as Pola et al.¹¹ used to categorize patients in their sample as "anemic" or "not anemic" and thus to justify transfusion or lack thereof.

Postsurgical Hb concentration, also estimated in g/dL, was reported during the 24 hours following surgery from a blood sample taken as control. And since the clinical record also didn’t include the argument whether or not to give blood transfusion during this period, it was decided to take Hb ≥ 10 g/dL as the criterion for not doing so, and <10 g/dL as the criterion for doing it, the same cutoff used by Foss et al.¹² to define the presence of anemia syndrome in patients> 70 years, the age group most likely to require surgery for hip fracture.

The duration of surgery was measured in minutes, which were recorded from the skin incision until it was completely closed; for cervicofemoral segment intervened, those reported by Zuckerman,¹³ were taken into account, including cervicofemoral or neck, intertrochanteric and subtrochanteric. The surgical technique of the procedure was to repair the fracture internally with screws, using either the angled plate or using a hemiprosthesis.¹³

Trans-surgical bleeding was estimated by the anesthesiologist or the orthopedic surgeon in charge of the surgery itself and is defined as the approximate volume lost during surgery and for purposes of this study it was another criterion used to justify whether or not to give blood transfusion at the time, considering it excessive loss when ≥ 400 ml, this cutoff point corresponding to more than 100% of the average loss documented by Foss et al.¹² in their sample, which is associated with postoperative development of anemia and hence the need for blood transfusion. Blood transfusion was defined as administering one or more packs of allogeneic blood before, during surgery, or during 24 hours after. It was accepted that the patient had received transfusion when the requisition or official request was in the medical record, or blood transfusion was mentioned in the surgical sheet, the anesthesiology sheet, or the daily surgical outcome sheet from the Orthopedics Service.

The data were analyzed first in a univariate way, using parametric tests for continuous unbiased data (Student t test for one average and for two independent averages) and nonparametric tests for categorical data (chi square). In a second step the variables that had p <0.05 were included in a model of binary logistic regression (Enter technique) from which the odds ratio (OR) and their respective confidence intervals of 95% were obtained (CI 95%). In keeping with the way Pola et al.11 analyzed the preoperative Hb and as Foss et al.¹² analyzed the postoperative Hb and trans-surgical bleeding, these variables were included in the logistic analysis as binary data for comparison between cases and controls. SPSS version 14.0 statistical package was used.

Results

We included 256 patients with a sample mean age of 78.2 ± 9.4 years (95% CI 77 to 79.3). One hundred eighty-three (71.5%) were women whose mean age (78.2 ± 9.1) was not significantly different from that of the men (78.1 ± 1) (p = 0.96). One hundred eighty-two (71.9%) had a chronic disease, one disease reported in 110 (43%), two in 59 (23%) and three in 13 patients (5.1%), of which type 2 diabetes mellitus was the most frequent (30.5%) followed by hypertension (19.1%). In the surgical aspect, the anatomic segment most frequently involved was the intertrochanteric (59.4%) and the technique most used for fracture repair was the application of a plate with screws (53.9%). The number of packets of blood transfused to patients who served as cases ranged from one (33%) to > 4 (12.7%). Complementary clinical and demographic data of the sample are presented in Table I.

There were 118 cases and 138 controls. Their average age (79.3 ± 9.9 versus 77.2 ± 8.8) was not significantly different (p = 0.08). The average preoperative Hb concentration (g/dL) was lower in cases (10.95 ± 1.2) than in controls (11.8 ± 1.3) (p <0.001), as was the average postoperative Hb concentration (8.13 ± 1.3 versus 9.65 ± 1.3; p <0.001). The average duration of surgery (in minutes) was in the case of 79.2 ± 23.1 min. and in controls 73.5 ± 20 min. (P = 0.01) and the trans-surgical bleeding (ml) of 361 ± 230 and 204.8 ± 102.8 (p <0.001), respectively.

Univariate analysis of categorical data did not identify statistically significant differences in gender distribution (RM 0.90, 95% CI 0.52 to 1.55), comorbidity (OR 0.68, 95% CI 0.39 to 1.18), the specific type of comorbidity (chi square p = 0.22) or the number of comorbid conditions (chi square p = 0.14). Those found statistically significant were: the preoperative Hb concentration (categorized) (OR 3.01, 95% CI 1.79 to 5.07), post-surgical Hb concentration (categorized) (OR 5.32, 95% CI 2.62 to 10.91), the cervicofemoral segment intervened (chi square p = 0.005), the surgical procedure done to repair the fracture (chi square p = 0.04) and volume (categorized) of trans-surgical bleeding (OR 6.86, 95% CI 3.34 to 14.10) (Table II).

Only the duration of the surgery was included as a continuous variable in the logistic regression model, and, as categories, pre and postoperative Hb and the volume of trans-surgical bleeding.

The chi-square test for goodness of fit (Hosmer-Lemeshow) of the model had a p value = 0.76, which dismissed the collinearity between variables. They were identified as statistically significant: the trans-surgical bleeding (≥ 400 versus <400 ml, RM 5.68, 95% CI 2.5 to 12.9) and preoperative Hb concentration (<11 g/dL vs. ≥ 11 g/ dL, RM 2.86 , 95% CI 1.47 to 5.56). Variables excluded from the model were: the duration of the surgery, the femoral segment involved, the type of surgery performed and postoperative hemoglobin concentration (<10 g/dL vs. ≥ 10 g /dL, RM 2.17, 95% CI 0.92 5.1) (chi square p> 0.05 for each variable). The data points are presented in Table III.

Discussion

There have been two clinical circumstances, pre or transsurgical, which increased the risk of allogeneic blood transfusion in patients with hip surgery, one of which is the volume of trans-surgical bleeding, which in just under 40% of cases was ≥ 400 ml and which the logistical model identified as the factor which increased by almost six times the likelihood of blood transfusion, which could result in influencing the high frequency (> 60%) of cases whose trans-surgical bleeding was <400 ml. This finding is consistent with those of Couvret et al.¹⁴ whose two-phases study analyzed the use of autologous or heterologous blood transfusion in knee or hip arthroplasty, reporting that in the first phase, the average blood loss is slightly higher than 500 ml and even so up to 95% of patients receive blood transfusion, but the frequency is reduced to 43% in the second phase of the study in which the average volume of blood loss is <650 ml. In the multicenter study by Walsh et al.¹⁵ including hip revision surgeries, up 58% receive allogeneic blood transfusion and in up to 29% of patients it is done trans-surgically. The loss of blood during this period is the only transsurgical variable identified as a risk factor for blood transfusion, seeing that for every ml lost, risk increases by 0.2% regardless of the lost volume (611-1151 ml).

Those results analyzed together with those obtained in the present study suggest that transsurgical volume lost, regardless of how much outside loss, is the criterion to be focused on the medical decision to give a blood transfusion to the patient, which on one hand may not have a solid physiological basis if one takes into account that the loss in case patients approximates the amount expected for the specific type of surgery,¹⁶ and that the reduction in Hb concentration produced would not have significant impact on patient morbidity or mortality,¹⁷ to which we can add the arguments of authors who report that losses of blood volume like those documented in this study can be treated with less risky alternatives such as crystalloid administration or plasma expanders, leaving^18,19 blood transfusion for patients who exhibit evidence of myocardial ischemia in trans- immediately post-operative, a major clinical problem that adults> 70 years could present.^13,19

On the other hand, having indicated blood transfusion regardless of the amount of the loss, including the group of cases with <400 ml, could be supported by the medical anesthetic argument that, making up that volume of blood would have the goal of maintaining cardiocirculatory stability and patient respiration during surgery and to prevent during or after surgery cardiovascular manifestations of anemic syndrome,^2,19 This argument could be applied to just over two thirds of cases of this series that were carriers of a chronic disease such as diabetes or high blood pressure, causes both directly related to the development of heart disease.

In this regard, Foss et al.¹² documented that the average transsurgical loss of 200 ml of blood is inducing postoperative anemia, which can affect the functional rehabilitation of patients with hip fracture, especially when they are carriers of a chronic comorbid condition and therefore at least 85% of patients in the series receive blood transfusion between the first and third postoperative day. In counterpoint, So-Osman et al.²⁰ found that while a short-term significant effect is seen on the quality of life of patients with hip or knee arthroplasty, it is not associated with the (acute) trans-surgical drop in Hb concentration, a finding also documented by other authors in patients with the same types of surgery.²¹

Just over half of the cases had preoperative Hb <11 g/dL, the second clinical circumstance positively associated with allogeneic blood transfusion, since this probability increased almost threefold. This finding agrees in part with other authors^10,22 identifying this cutoff or even a lower one, as the factor inducing the doctor to give a blood transfusion to the patient, even though it being low pre-surgery has not been a constant for this criterion. Salido et al.²² identified Hb as a risk factor inducing blood transfusion, although the concentration used by the surgeon to decide it varies between eleven and 14 g/dL, a trend also documented by Rashiq et al.,¹⁰ reporting that the preoperative Hb concentration is the factor associated with blood transfusion and even if the probability is decreasing as the number increases, the role of risk is 13.8 times greater when ≤ 12 g/dL and nearly four times even when it is > 14 g/dL. In this series 46% of case patients had Hb ≥ 11 g/dL, a fact which together with the rest sustains the inconsistency of Hb concentration as indicative of a solid criterion for blood transfusion.

Several explanations can be given to why there is so much variability in the cutoff of Hb to be considered as blood transfusion risk factor, and one of them would be the lack of attachment of the surgeon to any kind of recommendation regarding the use of blood and its derivatives,²³ an attitude that at once seems to be supported precisely in the lack of a universal consensus on cutoff from which justify the decision. Zuckerman¹³ emphasizes that at least 10 g/dL is appropriate for adults > 70 years, as concerns increased postoperative morbidity when this age group has less concentration of Hb, while others,^19,24 relying on existing recommendations, said they should be 6-8 g/dL for patients who do not have an acute severe pathology, but they also accept 10 g/dL as the appropriate figure for patients who have a history of cardiovascular disease or stroke.

Another explanation is the attention given by the surgeon or anesthesiologist to the Hb level (from <10 g/dL to 13 g/dL),²² taking it as a practical cutoff "trigger" to justify blood transfusion, especially when in the patient tachycardia or lowering blood pressure data are identified only by clinical and basic elements of electronic monitoring, which would be sufficient to interpret as the beginning of the homeostatic body's response to transsurgical blood loss then make the decision based on data, since it is not always possible to make a decision based on data obtained in a more sophisticated way in everyday practice, given that there is not always a special team for cardiovascular monitoring, nor is it always possible to perform invasive procedures to do this.²⁵

The two previous explanations could be reinforced with a third related to the risks associated with allogeneic blood transfusion and at one point these could modify the analysis of decision for or against it, because at least with hip surgery some authors^4,26 point out that it has no significant adverse effects on morbidity or mortality of patients at 30 and 90 days compared to the group that did not receive it, a controversial stance not shared by others who note serious consequences in patients of blood transfusion.^4,5,27 From the above it can be concluded that not rarely a blood transfusion for a patient based on their preoperative Hb number, could be a "preventive" action against cardiovascular morbidity or otherwise with or without blood loss in the trans-surgical and immediate postoperative, moreover because no medium term adverse reactions related to allogeneic blood transfusion would be expected.

A fact relatively little addressed by some authors who analyze the risk factors associated with blood transfusion in patients with hip fracture is related to post-surgical Hb concentration, which in the present study was a variable excluded from the logistic analysis but with a marked tendency to be a risk factor according to its 95%CI, and which would have increased slightly more than twice the risk of blood transfusion. Explanations for their exclusion could be methodological, as insufficient sample size to demonstrate differences (actually any) or "compensation" given by the frequency of patients (> 60%) who served as controls and had Hb < 10 g/dL.

Reasons why these patients were not "cases" has not been analyzed, even though beyond these explanations and in accordance with their exclusion as a risk factor, Danish authors²⁸ report that the postoperative Hb concentration up to 10 g/dL adults> 60 years with hip surgery is not necessarily an indicator of blood transfusion, a position shared by others,²⁹ saying that that concentration could be advisable in certain clinical circumstances. That these were the arguments by which 60% of controls with Hb <10 g/dL were not given transfusion, is unlikely.

Conclusions

In this study trans-surgical bleeding ≥ 400 ml and preoperative Hb <11 g/dL were identified as risk factors associated with allogeneic blood transfusion, while the postoperative concentration <10 g/dl had only strong tendency to increase the risk. To support the results obtained, it would be relevant to examine the orthopedic surgeons and anesthesiologists involved in hip surgeries, as to what criteria are used to decide whether or not to transfuse allogeneic blood for patients with hip surgery, outside of the preoperative, trans, and immediate postoperative period.

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