Clinical nursing care protocol for convalescent plasma transfusion in patients with COVID-19

Abstract

Introduction

The treatment of COVID-19 is still challenge. So convalescent plasma can be an important alternative of treatment. Protocols with nursing care during infusion is very important to guide an effective and safety care

Objective

to analyze the evidence in the literature on the action of convalescent plasma, of the use of protocols with nursing care to use convalescent plasma and build a nursing care protocol for transfusion in patients with COVID-19.

Methods

Methodological study carried out in two stages: scoping review. The search was done using the descriptors: convalescent plasma transfusion, convalescent plasma, and acute respiratory syndromes or COVID-19, to found protocols and effectiveness of convalescent plasm. Beside was done a specialist panel to build the protocol.

Results

Low-evidence studies have shown improvement in the clinical signs of COVID-19 using Convalescent Plasma, reduction or elimination of viral load, benefits in the production of lymphocytes, decreases C-reactive protein, increases titers of anti-SARS-CoV-2 antibodies, positive evolution in lung involvement identified by X-rays, decrease in hospitalization. No studies were found in the databases on the protocol for clinical nursing care in plasma transfusion. Therefore, a protocol was developed with the description of clinical nursing care to be performed before, during and after the transfusion by plasma: checking of vital signs and indicative signs of transfusion reaction, measurement of oxygen saturation, assessment of venous access and checking of the level of consciousness.

Conclusion

There are no evidence studies to support the use of plasma, nor anything related to bundles.

1. Introduction

COVID-19 usually manifests with flu-like symptoms such as fever, body pain, headache, loss of smell, taste and dyspnea, which can worsen and progress to Severe Acute Respiratory Syndrome (SARS) (Brazil, 2020a).

SARS is defined by the presence of dyspnea or the following signs of severity: Peripheral Capillary Oxygen Saturation (SpO₂) less than 95 % in room air, signs of respiratory distress or increase in respiratory rate assessed according to age, worsening in clinical conditions of the disease and hypotension regarding to usual blood pressure; individual of any age with acute respiratory failure during seasonal period (Brazil, 2020b).

Currently, alternatives have been sought for dealing with this disease, especially in patients whose clinical condition worsens. In this context, administration of plasma or immunoglobulin has been shown to be a potential treatment by reducing the mortality rate in patients with Systemic Respiratory Distress Syndrome (Soo et al., 2004;).

Studies testing convalescent plasma in patients with SARS and influenza A showed that in both cases there was a relative reduction in the mortality rate, as well as a decrease in viral load, interleukin 6, interleukin 10 levels and tumor necrosis factor. Plasma has been shown to be an important clinical strategy and an alternative treatment in patients with COVID-19 (Hung et al., 2011, Junior et al., 2020).

Thus, it is imperative to search for scientific evidence on the use of convalescent plasma in clinical management of patients with COVID-19, as well as on clinical nursing care protocols referring to it, in the context of the nursing care practice.

Based on the Population, Concept, and Context (PCC) Strategy of scope review, the guiding question was the following: what is the evidence on convalescent plasma transfusion and clinical protocols in the context of patient care with COVID-19?

To answer it, the objectives were to analyze the evidence found in the literature on the action of convalescent plasma in patients with COVID-19 and to build a protocol for clinical nursing care during convalescent plasma transfusion.

2. Method

Methodological study carried out in two stages, scoping review and a panel of experts to build the protocol.

The review was carried out in June 2020 and was based on the electronic bibliographic survey in MEDLINE (Medical Literature Analysis and Retrieval System Online) databases via Pubmed and LILACS (Latin American and Caribbean Literature in Health Sciences).Gray literature was accessed on academic Google and medical society websites to search for guidelines. The review followed the PRISMA protocol.

Primary search strategy carried out at MEDLINE:((((“plasma”[MeSH Terms] OR “plasma”[All Fields]) OR “plasmas”[All Fields]) OR “plasma s”[All Fields]) AND (((((((“covid 19″[All Fields] OR ”covid 2019″[All Fields]) OR “severe acute respiratory syndrome coronavirus 2″[Supplementary Concept]) OR ”severe acute respiratory syndrome coronavirus 2″[All Fields]) OR “2019 ncov”[All Fields]) OR “sarscov 2″[All Fields]) OR ”2019ncov“[All Fields]) OR ((”wuhan“[All Fields] AND (”coronavirus“[MeSH Terms] OR ”coronavirus“[All Fields])) AND (2019/12/1:2019/12/31[Date - Publication] OR 2020/1/1:2020/12/31[Date - Publication])))) AND ((((((”blood transfusion“[MeSH Terms] OR (”blood“[All Fields] AND ”transfusion“[All Fields])) OR ”blood transfusion“[All Fields]) OR ((”blood“[All Fields] AND ”component“[All Fields]) AND ”transfusion“[All Fields])) OR ”blood component transfusion“[All Fields]) OR ”blood component transfusion“[MeSH Terms]) OR ((”blood“[All Fields] AND ”component“[All Fields]) AND ”transfusion“[All Fields])).

The same search strategy was adapted to the LILACS database. All search strategies can be obtained by contacting the authors via email. The records were imported into the reference manager Endnote Basic (Clarivate Analytics), and duplication was removed.

Through the association of descriptive terms, a Boolean search (AND) was performed corresponding to the conceptual blocks to retrieve studies on the clinical protocol for convalescent plasma transfusion, convalescent plasma, and acute respiratory syndromes or COVID-19. The descriptors were determined from the controlled vocabularies MeSH (Medical Subject Headings Section), DeCS (Health Sciences Descriptors).

Inclusion criteria: studies and/or protocols on clinical care for convalescent plasma transfusion in adult and elderly patients with COVID-19 in available full texts. Exclusion criteria: studies containing only clinical trial records and/or summaries of integrative reviews; animal studies, duplicate studies keeping only one.

In MEDLINE via Pubmed, 552 articles were found, and 39 were fully read. In LILACS, 9 articles were found and only one fully read.

From the bibliographic data, a clinical care protocol for convalescent plasma transfusion was developed and then submitted to the panel of experts with national and international members. The panel was consisted of health experts who met at least one of the following criteria: the professional must have at least three years of experience in clinical nursing practice; must be assisting patients with a confirmed or suspected diagnosis of COVID-19 and a diagnosis of SARS.

According to the literature, there is no consensus on the number of evaluators to validate the items of an instrument. However, the number of experts will depend on the available sample with which the researcher can be in contact⁽⁷⁾. The sample was non-probabilistic, intentional and composed of 7 judges: 3 professionals with less than 10 years of professional training and experience in clinical practice and 4 professionals with more than 10 years of professional training and experience in clinical practice. Regarding the highest degree, 40 % had a PhD and 60 % specialization. As for professional performance, 40 % was a hematologist or oncologist nurse, 40 % a university professor and 20 % a nurse working in COVID-19 clinical units.

The specialists received a Likert scale to evaluate all the items of the nursing care protocol in convalescent plasma transfusion, with the options as follows:1- adequate, 2- adequate with changes, 3-inadequate, and a space for observations, in order to suggest necessary changes.

When any of the members disagreed with the text, suggestions were analyzed by the researchers in this study and changed in order to achieve the best version of the instrument. The changes were approved when 100 % of the Committee members (panel and researchers) agreed with the proposal. At the end of the evaluation, the authors analyzed the suggestions and made the final version of the protocol, which was reassessed and approved.

3. Results

The flowchart (Fig. 1 ) details the search steps for selecting the articles included in the review.

Fig. 1.

Flowchart of search and selection of articles.

In the analysis, 27 studies were included. Fig. 2 shows the data extraction after analytical reading of the selected studies.

Fig. 2.

Clinical studies on the use of convalescent plasma in the treatment of COVID-19.

From the analysis of the material, it is possible to state that studies on the use of convalescent plasma in the treatment of COVID-19 are incipient, and in nursing care studies there is no material available in national and international literature in databases searched. However, based on the transfusion scientific evidence generally submitted to expertanalysis of specialists who care patients with COVID-19, it was possible to produce a Nursing Care Protocol (Fig. 3 ).

Fig. 3.

Clinical nursing care protocol for convalescent plasma transfusion.

4. Discussion

The treatment of COVID-19 nowadays is a challenge. There are still no specific therapeutic agents or vaccines in the clinical treatment of patients affected by COVID-19. Antivirals and antibacterials are used, however, in the need for randomized controlled studies to determine the effectiveness of these drugs against this infectious agent (Wu and McGoogan, 2020, Lu, 2020). Studies have been pointing out to the possibility of using convalescent plasma as an adjuvant therapy for treating COVID-19 (Zeng et al., 2020, Barone and DeSimone, 2020, Knudson and Jackson, 2020).

The use of convalescent plasma was recommended as an empirical treatment during the Ebola virus pandemic in 2014 and as a protocol for the treatment of Midwestern Coronavirus Syndrome in 2015 (FDA, 2020).In addition, a study on the use of convalescent plasma during the influenza A pandemic demonstrated a reduction in viral load in the respiratory tract and mortality (Hung et al., 2011).

On March 24, 2020, FDA (Food and Drug Administration) addressed how patients should be selected and when to use convalescent plasma, namely: identifying subjects and confirming molecularly in case of COVID-19 after being asymptomatic for 14 days, then testing them and confirm that there is no sign of infection by COVID-19 (nasopharyngeal CRP). Therefore, these are the patients eligible to donate convalescent plasma (Food and Drug Administration, 2020, Knudson and Jackson, 2020). It is also suggested that convalescent plasma has at least 1: 160 titers of SARS-CoV-2 neutralizing antibodies. If this is not possible, FDA considers the 1:80 titration as acceptable.

Low-evidence studies indicate that the use of convalescent plasma for COVID-19 reduces mortality rates, improves the clinical respiratory signs of the disease, decreases C-reactive protein, increases titers of anti-SARS-CoV-2 antibodies, reduces and/or eliminates viral load, decreases infiltration and lung involvement and shortens hospital stay (Valk et al., 2020, Kong et al., 2020, Rajendran et al., 2020, da Silva, 2020).

Despite these results, a randomized clinical trial conducted in China did not show significantly greater improvement in patients treated with plasma when compared to untreated patients, although plasma therapy demonstrated a reduction in viral load more quickly (72 h) (Li et al., 2020). Corroborating this study previously referred, a quick review following the Cochrane methodology and a systematic review highlighted that there is no robust evidence to confirm the effectiveness and safety on the use of plasma in patients with COVID-19 (Devasenapathy et al., 2020, Valk et al., 2020). In addition, a case series study conducted in China highlights that the use of plasma in patients with severe COVID-19 does not reduce mortality (Zeng & Xiang, 2020).

The use of convalescent plasma needs to be evaluated for its effectiveness and efficacy, although, in the absence of specific treatment, plasma can be considered a promising technology in the treatment of COVID-19 since important adverse effects related to its use were not identified (Duan et al., 2020, Sahu et al., 2020, Devasenapathy et al., 2020).

Within the scope of their clinical approach, it is up to nurses to adopt qualified and scientific intervention in the face of convalescent plasma transfusion since this technology has been used as an alternative in the absence of specific promising treatment for COVID −19.

No studies addressing the clinical care protocol for plasma transfusion to patients with COVID-19 were found. Thus, based on clinical experience and studies (INS, 2020; Wallis et al., 2014) that address infusion care in general, the aspects/actions that the nurse must follow in the context of convalescent plasma transfusion are highlighted below (Fig. 4 ).

Fig. 4.

Nursing care to perform convalescent plasma transfusion.

5. Conclusion

In this review, the authors did not find high-quality studies to prove that convalescent plasma is effective in the treatment of COVID-19, nor studies on clinical protocol with nursing care for transfusion of convalescent plasma in patients with COVID-19. Therefore, a protocol was developed in accordance with infusion studies in generaland the clinical experience of the authors and the examiners. This protocol established the main nursing care in the context of plasma transfusion as follows: assessment of vital signs, level of oxygen saturation, characteristics of venous access, indicative signs of transfusion reactions such as changes in heart and respiratory rate and level of consciousness (if possible).

Among the study limitations, the lack of high-evidence studies with robust methodologies to guarantee efficiency and safety of the use of convalescent plasma in the treatment of COVID-19 stands out.

Further studies are suggestedwith clinical protocols developed in nursing care settings with patients affected by COVID-19.

6. Relevance to clinical practice:

This study build the first protocol of clinical care to the transfusion of Plasm convalescent based on literature and specialist panel, subsidizing clinical practice.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.