Blood transfusion can be lifesaving, but it can also be life-threatening because of adverse transfusion reactions.1 2,3 4
Reporting the adverse events of transfusion is an essential component of a hemovigilance system.5 6 7 5,8
Patients’ clinical status should be closely monitored during transfusion and recorded in a health care database. Vital signs are measurements of the body’s most basic functions that help medical professionals evaluate patient health status.9,10 4 acute transfusion reactions (ATRs) and their timely assessment can considerably improve their management. Our hospital’s information system comprises both institutional policies and a hemovigilance system for blood transfusion. Specifically, a Wi-Fi–based vital signs monitoring system automatically records and transmits blood pressure, pulse rate, and body temperature to hospital information system (HIS) database.
In this study, we retrospectively compared patients’ vital signs and other laboratory data before and after blood transfusion and analyzed the data to identify potential clinical characteristics associated with the developing of ATRs.
METHODS
Study Population
This retrospective study collected data on transfusions conducted during 2011–2015 using the computerized HIS of Taichung Tzu-Chi Hospital (499 beds). A flowchart of the enrollment process of this study cohort is shown in Figure 1 . This study was approved by the Research Ethics Committee of Taichung Tzu-Chi Hospital (REC 103-42).
FIGURE 1: Flowchart of study events included in this retrospective study.
Hospital Hemovigilance Online Reporting System
To improve the quality of clinical transfusion care, a patient-focused online reporting system was created and implemented in our HIS in 1997 for monitoring transfusion practices (Fig. 2 A). Since 2010, a wireless vital signs monitoring system (Dinamap ProCare 300 Vital Signs Monitor; GE Inc, Milwaukee, Wis) has been integrated into the transfusion management system. The English version of the transfusion reaction reporting web page is shown in Fig. 2 B. The web page comprises the following four main components: (1) patient information, including medical record number, sex, age, blood type, doctor’s name, diagnosis, and laboratory data; (2) cloud-based electronic vital signs data, including body temperature, pulse rate, respiratory rate (using the temperature-pulse-respiration reporting system), and blood pressure; (3) use of blood components: indication for transfusion, volume transfused, and start and end times of transfusion; and (4) adverse transfusion reactions: symptoms or signs that occurred during transfusion or within the subsequent 24 hours. All blood components for transfusion were prescribed by a medical practitioner. To use our reporting system, nurses simply click on the appropriate icon and enter the reporting procedure information throughout the transfusion process. Patients’ vital signs are automatically recorded at three time points: before transfusion, 15 minutes after transfusion initiation, and after transfusion of each blood component unit. In addition, patients are asked whether they experience any symptoms during the blood transfusion. The vital signs and symptoms are monitored every 8 hours up to 24 hours after transfusion, and the reporting system automatically connects the nursing record system to the blood bank physician system. In our online reporting system, patients receiving transfusions without any signs and symptoms are identified as “no transfusion reaction.” If one or more signs or symptoms occur, they are documented in the electronic medical records. If any ATRs occur, a notification is automatically sent to a doctor for confirmation. Hospital hemovigilance online reports are recorded for each blood unit transfused, and each unit is considered a single transfusion event.
FIGURE 2: Online HIS for monitoring ATRs. A, A patient-focused online reporting system at the hospital. B, English version of the online reporting webpage for adverse events of blood component transfusion.
Vital Signs Checking and Laboratory testing
There are four primary vital signs: body temperature, blood pressure, pulse rate, and breathing rate. The forehead thermometer is a fast and easy way to measure body temperature. Blood pressure and pulse rate were evaluated using an electronic device (Dinamap ProCare 300 Vital Signs Monitor; GE Inc, Milwaukee, Wis). Clinical blood samples from patient were evaluated for complete blood cell counts and white blood cell with differential analysis using the Sysmex XE-5000 hematology analyzer (Sysmex Co, Kobe, Japan).
Classification of ATRs by Severity
In this study, ATRs were categorized by severity (i.e., mild, moderate, and severe/life-threatening or grades 1–3, respectively), which were adapted from the blood transfusion safety handbook of the World Health Organization.4,11 12 Fig. 2 B), patients receiving transfusions without any signs and symptoms are identified as “No transfusion reaction.” If any ATRs occur, a notification is automatically sent to a doctor for confirmation.
Statistical Analysis
Continuous variables were expressed as means ± standard deviation, and categorical data were expressed as frequencies and percentages. One-way analysis of variance test was used for continuous variables. Pearson’s χ2 test was used for categorical variables. Independent predictors eligible for inclusion are as follows: sex, forehead temperature (34°C–37.5°C, >37.5°C), pulse rate, respiratory rate, systolic pressure (<90 mm Hg, 90–110 mm Hg, >110 mm Hg), diastolic pressure (<70 mm Hg, 70–90 mm Hg, >90 mm Hg), hemoglobin, platelet counts, leukocyte counts (<5 ×103 /μL, 5–15 ×103 /μL, >15 ×103 /μL). Multivariate logistic regression models were used to identify associated factors of developing ATRs (mild, moderate, and severe/life-threatening).13 P < 0.05.
RESULTS
Data Collection
The data sources from HIS, including patient information, laboratory data, ATRs, and a detailed bedside database were used. The data were cleaned (purged of inconsistent and/or nonsense values), organized, and merged to create files for the analysis. A transfusion episode was defined as one or more blood component units issued at the same time. As shown in Fig. 1 , between 2011 and 2015, there were 59,725 transfusion episodes included in this retrospective study. However, online reports missing data on blood pressure (n = 18), pulse rate (n = 17), temperature/respiratory rate (n = 1927), leukocyte counts (n = 12,871), hemoglobin (n = 12), and platelet count (n = 58) were excluded. The inclusion criteria were 18 years or older. The frequencies of ATRs were calculated by dividing the number of cases of such signs and symptoms by the total number of study events. A total of 44,691 study events were included, of which 1586 (3.5%) were reportable ATR events.
Pattern of Transfusion-Related Signs and Symptoms
There are 1586 ATR reporting events were automatically transmitted to the HIS database system, and 1707 transfusion-related signs and symptoms were observed (Table 1 ). Elevated body temperature was the most common. Of 1267 reports (74.23% of reportable ATRs), body temperature increase of 1°C to 2°C, body temperature increase of greater than 2°C, and overall body temperature of greater than 38°C occurred in 946 (55.42%), 228 (13.36%), and 93 (5.45%) cases, respectively. The most common clinical signs and symptoms in these cases related to allergic reactions were itching (4.98%, n = 85), urticaria (4.80%, n = 82), and blush (1.23%, n = 21), followed by chills (10.78%, n = 184), dyspnea (2.05%, n = 35), nausea/vomiting (0.41%, n = 7), shock (0.29%, n = 5), headache (0.29%, n = 5), chest pain/abdominal pain/backache (0.23%, n = 4), hemoglobinuria (0.06%, n = 1), and none of the previously mentioned uncomfortable symptom (0.64%, n = 11).
TABLE 1 -
Transfusion-Related Signs and Symptoms Recorded on the Online Reporting System
Sign or Symptom
No. Case
%
Body temperature increase of 1–2°C
946
55.42
Fever
228
13.36
Chills
184
10.78
Body temperature increase of 2°C
93
5.45
Itching
85
4.98
Urticaria
82
4.80
Blush
21
1.23
Dyspnea
35
2.05
Nausea/vomiting
7
0.41
Shock
5
0.29
Headache
5
0.29
Chest/abdominal pain/backache
4
0.23
Hemoglobinuria
1
0.06
None of the above mentioned
11
0.64
Total 1586 ATR reporting events
1707
100.00
Characteristics of the 44,691 Study Events With and Without ATRs
Table 2 summarizes the pretransfusion characteristics of the 44,691 transfusion episodes. The mean ± SD age was 65.6 ± 15.5 years, and the median (interquartile range) age was 68 (18–105) years. Of the 1586 ATR events, 790 (49.8%) occurred in women and 796 (50.2%) in men. Compared with patients without ATRs, those with ATRs exhibited elevated body temperature (forehead temperature >37.5°C, 5.5% versus 3.8%, P = 0.001), abnormal systolic pressure (< 90 mm Hg or >110 mm Hg, 78.9% versus 75.1%, P = 0.001), abnormal diastolic pressure (<70 mm Hg or >90 mm Hg, 55.9% versus 59.9%, P = 0.001), and abnormal leukocyte count (<5×103 /μL or >15×103 /μL, 40.2% versus 36.5%, P = 0.003).
TABLE 2 -
Baseline Characteristics of All Included Study Events With and Without ATRs
Characteristic
All Study Events (n = 44,691)
With ATRs (n = 1586)
Without ATRs (n = 43,105)
P
Age, y
65.6 ± 15.5, 68 (18–105)
63.1 ± 16.1, 64 (18–102)
65.7 ± 15.5, 68 (18–105)
<0.001
Sex
Female
19,903 (44.5%)
790 (49.8%)
19,113 (44.3%)
<0.001
Male
24,788 (55.5%)
796 (50.2%)
23,992 (55.7%)
Vital sign
Pulse rate, beat per minute
89.5 ± 19.6
91.0 ± 19.9
89.4 ± 19.5
0.002
Respiratory
19.7 ± 3.9
19.8 ± 4.1
19.7 ± 3.9
0.398
Body temperature
Normal (34–37.5°C)
42,967 (96.1%)
1499 (94.5%)
41,468 (96.2%)
0.001
Abnormal (>37.5°C)
1724 (3.9%)
87 (5.5%)
1637 (3.8%)
Systolic pressure
Normal (90–110 mm Hg)
11,064 (24.8%)
335 (21.1%)
10,729 (24.9%)
0.001
Abnormal
33,627 (75.2%)
1251 (78.9%)
32,376 (75.1%)
Diastolic pressure
Normal (70–90 mm Hg)
17,964 (40.2%)
700 (44.1%)
17,264 (40.1%)
0.001
Abnormal
26,727 (59.8%)
886 (55.9%)
25,841 (59.9%)
Hb, g/dL
9.0 ± 2.5
8.9 ± 2.6
9.0 ± 2.5
0.161
Platelet counts, ×103 /μL
165.8 ± 125.1
175.5 ± 132.6
165.4 ± 124.9
0.002
Leukocyte counts
Normal (5–15 × 103 /μL)
28,339 (63.4%)
949 (59.8%)
27,390 (63.5%)
0.003
Abnormal
16,352 (36.6%)
637 (40.2%)
15,715 (36.5%)
Continuous variables were reported as mean ± SD. Categorical variables were reported as counts (%); one-way analysis of variance test was used for continuous variables;
Pearson's χ2 test was used for categorical variables.
Potential Associated Factors for ATRs
Multivariate logistic regression models were employed to estimate the associations (ORs and 95% CI) between pretransfusion predictors and in developing ATRs. In this study, ATRs were categorized as mild, moderate, and life-threatening. We used multivariable logistic regression models to calculate absolute risk differences while adjusting for possible independent variables, including sex, body temperature, pulse rate, respiratory rate, systolic pressure, diastolic pressure, hemoglobin count, platelet count, and leukocyte count. Transfusion patients with leukocyte counts below the normal range (5–15 × 103 /μL) were associated with mild ATRs (OR = 2.38, 95% CI = 1.68–3.35, P < 0.001) (Fig. 3 A). Multivariate analysis indicated that patients with elevated body temperature (forehead temperature >37.5°C) were associated with moderate ATRs (OR = 1.55, 95% CI = 1.22–1.98, P < 0.001) (Fig. 3 B). Patients with diastolic pressure above the normal range (>90 mm Hg) were associated with life-threatening ATRs (OR = 1.78, 95% CI = 1.06–2.99, P = 0.030) (Fig. 3 C).
FIGURE 3: Potential risk for ATRs. A, Odds ratio for grade 1 ATRs. B, Odds ratio for grade 2 ATRs. C, Odds ratio for grade 3 ATRs.
DISCUSSION
Blood transfusions are lifesaving, and clinicians and laboratorians endeavor to ensure that blood transfusions are as safe as possible for patients. Each blood product transfusion is associated with some degree of potential risk of an acute or late adverse reaction.14 15 16,17 Fig. 2 ).
We identified 1267 reports (74.23% of reportable ATRs) of febrile nonhemolytic transfusion reactions (FNHTRs), including body temperature increase of 1°C to 2°C (55.42%, n = 946), body temperature increase of greater than 2°C (5.45%, n = 93), and fever (13.36%, n = 228) (Table 1 ). The incidence of FNHTR has been reported to vary from 17% to more than 54%.14,18–20 4,21 5 22 23,24 24 23,25–27
At our hospital, the incidence of adverse transfusion reactions was 3.5% (1586/44,691) blood units transfused (Table 2 ). Furthermore, we reported that vital signs monitoring and leukocyte count before transfusion were significantly associated with the subsequent occurrence of ATRs (Fig. 3 ). Currently, leukocyte count is not comprehensively performed in pretransfusion assessments.28
This study has several limitations. First, this was a longitudinal observational study. The data were limited to those files available in the computerized database of the HIS. Second, some online records were incomplete because of transmission errors. However, during the data transmission process, some data may be lost during the Wi-Fi signal loss or device not online (thermometer) and resulted failure of archive data. In addition, some data may incomplete because of the human error, which nurses forget to measure vital sign before or after transfusion. In particular, respiratory rate was less frequently recorded than other vital signs.29,30 Fig. 1 ). Fourth, delayed transfusion reactions could not be evaluated in the study setting. However, any signs and symptoms occurring within 24 hours of a transfusion are required to be reported for all transfusion patients. Hence, ATRs were the focus of this study. Based on the study results, prompt and effective preventive strategies, such as recognizing increased body temperature as an early sign, can be developed for ATRs.
CONCLUSIONS
In summary, we reported on the patient-focused hemovigilance system implemented in our hospital. Establishing a standard procedure that uses Wi-Fi to transmit patients’ vital signs and collect data correctly during the whole blood transfusion procedure is vital. A well-established hospital hemovigilance system not only reduces possible human errors but also improves the safety of blood transfusion. It is an essential step toward nationwide hemovigilance. Our results indicated that patients with leukopenia, elevated body temperature, and high diastolic blood pressure were associated with ATRs occurrence.
ACKNOWLEDGMENTS
The authors thank Dr. Chin-Tun Hung for his guidance and helpful discussions about statistical analyses.
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