Abstract
Introduction: Blood transfusion is a remedial intercession and a fundamental fragment of Current medical services framework. As indicated by the WHO the bonding is an action of moving blood or blood-items taken from a giver into the vasculature and in this manner the flowing blood of the recipient, done by embeddings an IV Needle/Catheter in the patient and followed by use of blood or the blood-items. In any case, the dangers of non-irresistible difficulties have gotten more obvious. These nonirresistible complexities called as adverse transfusion reactions (ATRs) can either be intense in nature or follow a postponed course. Transfusion reaction is any unanticipated impact that happens in a patient during or subsequent to accepting blood and the blood-items. These can be agreed as intense transfusion responses, happening inside 24 hours of transfusion and deferred bonding responses happens inside the space of days or long periods of bonding. Intense and moderate responses can be additionally classified as insusceptible interceded and non-immune-intervened. Methodology: The prospective and observational study was carried at Department of Pediatric Oncology & Thalassemia unit for a period of 6 months. The population required for the study includes patients undergoing blood transfusions. Results: In study data out of 83 units, 61 units of PCV was transfused (73.49%), 6 units of Platelet was transfused (7.22%), 14 units of Whole Blood was transfused (16.86%), 1 units of Fresh Frozen Plasma was transfused (1.20%), and 1 units of RBC was transfused (1.20%). The chance of an ADR occurrence with every transfusion is 0.4. The P value is less than .05 so it is statically significant. It is positively correlated, having a high impact on the number of transfusion and rate of incidence of ADR. Conclusion: While a Blood transfusion is given for unavoidable situation the important factors to be kept under consideration are ADR following transfusion which can be the common complication observed. The study also concludes that the rate of incidence of ADR is increased significantly as the number of transfusion increases.
Keywords: adverse drug reactions, blood products, pediatrics, oncology
Introduction
Blood transfusion is a remedial intercession and a fundamental fragment of Current medical services framework. As indicated by the WHO the bonding is an action of moving blood or blood-items taken from a giver into the vasculature and in this manner the flowing blood of the recipient, done by embeddings an IV Needle/Catheter in the patient and followed by use of blood or the blood-items. 1
In any case, the dangers of non-irresistible difficulties have gotten more obvious. These non-irresistible complexities called as adverse transfusion reactions (ATRs) can either be intense in nature or follow a postponed course. 2
Transfusion reaction is any unanticipated impact that happens in a patient during or subsequent to accepting blood and the blood-items. These can be arranged as intense transfusion responses, happening inside 24 hours of transfusion and deferred bonding responses happens inside the space of days or long periods of bonding. Intense and moderate responses can be additionally classified as insusceptible interceded and non-immune intervened. 3 , 9
Different types of ADR (Adverse drug reaction) were observed after the transfusion of blood and its components. The observed ADR were fever, chills, urticarial, hepatomegaly due to the transfusion of whole blood, PCV, and Fresh-Frozen Plasma. As the number of transfusion increases the incidence of ADR occurrence is also increased. 8
Information on conceivable unwanted impacts will be valuable to forestall their event and help in clinical administration. Hemovigilance is intended to identify and dissect all untoward impacts of blood-bonding to address their motivation and forestall the Repeat 4
Methodology and Eligibility Criteria
The project was carried-out in Department of Pediatric Oncology & Thalassemia unit. The population required for the study includes patients undergoing blood transfusions. The study design selected was prospective and observational design. A period of 6 months was determined for the purpose of data collection and observation of adverse reactions.
In the study, patients of both genders (male and female) of ages less than equal to 18 years were considered. Also, thalassemia patients and patients with any type of cancer who were ready to accept the protocols were included. Patients enrolled in other study and with any solid tumor were excluded (Refer Figure 1).
Figure 1.
Study flow chart.
Results
Out of 63 subjects, 38 (60.48%) subjects were found to be male and 25 (39.38%) samples were found to be females respectively (Refer Table 1). The educational status of the 63 subjects were taken, out of which 4 subjects were in Pre-Primary (6.34%), 28 subjects were in Primary (44.44%), 10 subjects were in SSLC (secondary school leaving certificate; 15.87%), 1 subjects was in PUC (Pre-university course; 1.58%), and 20 subjects did not go to school (Refer Graph 1).
Table 1.
Distribution of Age and Gender.
| Distribution of age and gender | ||||
|---|---|---|---|---|
| Age (y) | No. of male | % Male | No. of female | % Female |
| 0-4 | 11 | 17.46 | 7 | 11.11 |
| 5-9 | 9 | 14.46 | 9 | 14 |
| 10-14 | 8 | 12.69 | 8 | 12.69 |
| 15-18 | 10 | 15.87 | 1 | 1.58 |
| Total | 38 | 60.48 | 25 | 39.38 |
Graph 1.
Educational status of the patients.
Out of 63 subjects, 5 subjects were diagnosed with ALL (Acute Lymphoblastic leukemia; 7.93%), 3 subjects were diagnosed with HLH (Hemophagocytic lymphohistiocytosis; 4.76%), 41 subjects were diagnosed with Thalassemia (65.07%), 2 subjects were diagnosed with Aplastic Anemia (3.17%), 1 subject was diagnosed with Megaloblastic anemia (1.58%), 1 subject was diagnosed with Hemolytic Anemia (1.58%), 1 subject was diagnosed with Leukemia with Iron Deficiency Anemia (1.58%), 5 subjects were diagnosed with Pre-B ALL (B-cell acute lymphocytic leukemia; 7.93%), 1 subject was diagnosed with AML (Acute myeloid leukemia; 1.58%), and 31 subjects were diagnosed with Acute Leukemia (4.76%) (Refer Table 2).
Table 2.
Disease Diagnoses.
| Diagnosis | ||
|---|---|---|
| Disease | No. of sample | % |
| ALL | 5 | 7.93 |
| HLH | 3 | 4.76 |
| Thalassemia | 41 | 65.07 |
| Aplastic anemia | 2 | 3.17 |
| Megaloblastic anemia | 1 | 1.58 |
| Hemolyic anemia | 1 | 1.58 |
| Leukemia with iron deficiency anemia | 1 | 1.58 |
| Pre-B ALL | 5 | 7.93 |
| AML | 1 | 1.58 |
| Acute leukemia | 3 | 4.76 |
| Total | 63 | 99.94 |
Out of 63 subjects, 44 subjects were subjected to PCV Transfusion (69.84%), 4 subjects were subjected to Platelet Transfusion (6.34%), 14 subjects were subjected to Whole Blood Transfusion (69.84%), 1 subject was subjected to Fresh Frozen Plasma Transfusion (1.58%), and 1 subject was subjected to RBC Transfusion (1.58%) (Refer Table 3).
Table 3.
Types of Transfusion and Multiple Transfusion.
| Types of transfusion | Multiple transfusion | |||
|---|---|---|---|---|
| Types of transfusion | No. of subject transfusion | % | Total no. of units | % |
| PCV | 44 | 67.80 | 61 | 73.49 |
| Platelet | 4 | 6.30 | 6 | 7.22 |
| Whole blood | 14 | 22.0 | 14 | 16.86 |
| Fresh frozen plasma | 1 | 1.52 | 1 | 1.20 |
| RBC | 1 | 1.52 | 1 | 1.20 |
| Total | 64 | 99.04 | 83 | 99.97 |
Out of 83 units, 61 units of PCV was transfused (73.49%), 6 units of Platelet was transfused (7.22%), 14 units of Whole Blood was transfused (16.86%), 1 units of Fresh Frozen Plasma was transfused (1.20%), and 1 units of RBC was transfused (1.20%) (Refer Table 3 and Graph 2).
Graph 2.
Multiple transfusion.
Out of 63 samples, 9 patients (PCV-5, Whole Blood-4: 14.28%) had fever, 8 patients (PCV-7, Fresh Frozen Plasma-1: 12.69%) had chills, 5 patient, (PCV-5: 1.58%) had rash, 11 patient had (PCV-7, Whole Blood-4: 17.46%) had hepatomegaly and 34 patients had no reactions. (Refer Table 4).
Table 4.
ADR Occurrence in Relation With Type of Transfusion.
| Types of ADR | Types of transfusion | Frequency | Incidence (%) |
|---|---|---|---|
| Fever | PCV | 05 | 9 (14.28) |
| Whole blood | 04 | ||
| Chills | PCV | 07 | 8 (12.69) |
| Fresh frozen plasma | 01 | ||
| Urticaria | PCV | 01 | 1 (1.58) |
| Hepatomegaly | PCV | 07 | 11 (17.46) |
| Whole blood | 04 | ||
| None | 34 | 00 (53.96) | |
| Total | 63 (99.97) | ||
The ADR probability score according to Naranjo Scale for 29 patients, definite ADR was observed in 8 patients, probable ADR was observed in 21 patients, and other 54 patients had no ADR (Refer Table 5).
Table 5.
ADR Probability Scale Score.
| S. no | Types of ADR | Incidence | Naranjo’s scale | |
|---|---|---|---|---|
| Category | Frequency | |||
| 1. | Fever | 9 (14.28%) | Definite | 3 |
| Probable | 6 | |||
| 2. | Chills | 8 (12.69%) | Definite | 1 |
| Probable | 7 | |||
| 3. | Urticaria | 1 (1.58%) | Definite | 1 |
| 4. | Hepatomegaly | 11 (17.46%) | Definite | 3 |
| Probable | 8 | |||
| 5. | None | 34 (53.96%) | ||
The mean and standard deviation for the Types of ADR and types of transfusion was observed to be 1.32 ± 1.554 and 3.56 ± 1.028 respectively.
In Pearson correlation, types of ADR and types of transfusions are positively correlated but it is not statistically significant because the P value is more than .05 (Refer Tables 5 and 6).
Table 6.
Correlation of Types of ADR and Types of Transfusion.
| Types of ADR | Types of transfusion | |
|---|---|---|
| Types of ADR | ||
| Pearson correlation | 1 | .090 |
| Sig. (2-tailed) | .484 | |
| N | 63 | 63 |
| Mean | 1.32 | — |
| Std. Deviation | 1.554 | — |
| Types of transfusion | ||
| Pearson correlation | .090 | 1 |
| Sig. (2-tailed) | .484 | 63 |
| N | 63 | |
| Mean | — | 3.56 |
| Std. Deviation | — | 1.028 |
The mean and standard deviation for the Types of ADR and number of transfusion per person was observed to be 1.32 ± 1.554 and 1.00 ± 1.760 respectively.
In Pearson correlation, types of ADR and number of transfusions are positively correlated and statistically significant with P value less than .05.
The chart represents that the rate of incidence of ADR is increased as the number of transfusions increase (Refer Table 7).
Table 7.
Correlation of Types of ADR and Number of Transfusion.
| Types of ADR | Number of transfusion per person | |
|---|---|---|
| Types of ADR correlation | ||
| Pearson | 1 | .478** |
| Sig. (2-tailed) | — | .000 |
| N | 63 | 63 |
| Mean | 1.32 | — |
| Std. Deviation | 1.554 | — |
| Number of transfusion per person | ||
| Pearson correlation | .478 | 1 |
| Sig. (2-tailed) | .000 | — |
| N | 63 | 63 |
| Mean | — | 1.00 |
| Std. Deviation | — | 1.760 |
Correlation of Types of ADR and Number of Transfusion. among Pediatric Haemato-Oncology and Thalassemia Patients
The chance of an ADR occurrence with every transfusion is 0.4. The P value is less than .05 so it is statically significant. It is positively correlated, having a high impact on the number of transfusion and rate of incidence of ADR.
The R value of multiple transfusion with ADR occurrence (.4) gives a significant result at P value less than .05 so it reveals the correlation between the respective variables.
The result of regression analysis shows that every unit increases in blood transfusions to the patient occurrence of ADR significantly increases by 0.478 times. Thus, 22.8% of variance (adjusted R2 = .228).
The ADR can be explained by single blood transfusion at P value less than .05. Thus, the results are significantly significant (53.96%) didn’t suffer from any adverse reaction (Refer Table 8).
Table 8.
Regression Analysis of ADR Occurrence in Relationship to Number of Transfusions.
| Model | R | R 2 | Adjusted R2 | Std. error of the estimate |
|---|---|---|---|---|
| 1 | .478 | .228 | .216 | 1.376 |
| Model | df | F | Sig. | |
| Regression | 1 | 18.051 | 0.001* | |
| Residual | 61 | |||
| Total | 62 | |||
Discussion
This study demonstrates the correlation and regression for types and number of Blood transfusions versus transfusions induced ADR among pediatric haemato-oncology and thalassemia patients at the tertiary care Hospital which was an Prospective and observational study. This study was conducted especially in pediatric population (0-18 years) of both in male and female.
Stainsby et al, 1 it was observed 153 (47.7%) subjects of male patients were included and 163 (50.8%) subjects of female patients were included. In current study, 38 (60.48%) subjects of male patients were included and 25 (39.38%) subjects of female patients were included.
Present findings indicating that total of 83 units, out of which 61 units of PCV (73.49%), 6 units of platelets (7.22%), 14 units of Whole Blood (16.86%), 1 units of Fresh Frozen Plasma (1.20%), and 1 units of RBC (1.20%) was transfused.
In study conducted by Tushar it was observed that a total no. of 8121 units of whole blood and components were given. These comprised whole blood (5535 [68.15%]), packed red blood cells (901 [11.09%]), Fresh-Frozen-plasma (1180 [14.5%]), and Platelets (505 [6.21%]). 6
Howsoever, it was seen in our study that out of 63 patients enrolled, 11 patients had from hematomegaly (17.46%), 9 patients had fever (14.28%), 8 patients had chills (12.69%), 1 patient had rashes (1.58%), and 34 patients didn’t suffer from any adverse reactions. Therefore in a study it was observed that almost half of the patients (47.6%) suffered from ADR and these patients only required symptomatic treatment or no treatment.
In a similar report by Bhattacharya, Negi G et al, 4 event of adverse transfusion reaction was 0.18% (105 reactions out of [56 503 units] of blood and it’s segment transfused).
Additionally in a report by Negi et al, Blood-transfusion security: Investigation of unfriendly responses at the blood donation center of a tertiary consideration place (38 013 units) of blood and it’s segments that had been given, 101 (0.2%) cases had an ATR. The most notable reaction was negatively powerless—34/101 (33.6%) followed by Febrile—26/101 (25.7%). Various reactions included bonding related exceptional Lung-injury in-6/101 (5.9%) cases, and immune reactions were found in 19/101 (18.8%) cases. 5
In the current study there is a positive and significant correlation with types of ADR and number of transfusion. Also there is a positive correlation with the type of ADR and types of transfusion but it is not statistically significant.
Similarly, in a study conducted by Hendrickson and Hillyer, it was observed that the most Serious ADR was caused because of the Acute transfusion reactions or events. Also there was a significant correlation with types of ADR and number of transfusion. It also indicates a high impact on number of transfusion and rate of incidence of ADR. Each blood item that was transfused conveys a little danger of an intense or late unfavorable impact. The most well-known prompt ADR to transfusion are fever, chills and urticaria. In specific instances of gentle urticarial responses or the presence of rehashed chill-fever responses in duplicate transfused patients.7,10
Conclusion
This study conducted on the detection of adverse reactions in patients receiving blood transfusions concludes that the occurrence of adverse reactions during or after the blood transfusion was caused by numerous reasons and the main reason for most of the reactions seen was directly related to the number of blood or its products being transfused. . .
While a Blood transfusion is given for unavoidable situation the important factors to be kept under consideration are ADR following transfusion which can be the common complication observed. The study also concludes that the rate of incidence of ADR is increased significantly as the number of transfusion increases.
Acknowledgments
Acknowledgment to Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi, Karnataka, India; Department Paediatric Haemato-Oncology & Thalassemia Unit of KLE’s Dr. PKH & MRC, KLE Cancer Hospital Belagavi, Karnataka, India; and Ethical Committee for Human Subjects, KAHER, Belagavi Karnataka, India.
Footnotes
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
ORCID iD: Manjula Gudhoor 
https://orcid.org/0000-0002-7173-6408
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