Research Proposal on Traumatic Brain Injury

Introduction

Traumatic brain injury (TBI) is one of the leading causes of disability and deaths worldwide (Dewan et al., 2012). It has been approximated that about one and a half million people die of TBI every year (Boudreau et al., 2017). The Traumatic brain injuries become dangerous if they are followed by intracranial hemorrhage (ICH) within 24 hours of injury. Intracranial hemorrhage predisposes individuals to coagulopathy that in turn leads to higher mortality risks of the hemorrhage (Brown et al., 2015). Tranexamic acids are being increasingly used in the Emergency Department (ED) in traumatic brain injury management in Australia's healthcare settings (NSW Health, 2007; NSW Health, 2012). The number of TBI cases reported annually amounts to about 2.5 million, therefore, due to this large figure there is need to determine a better way of reducing the occurrences (Xiong et al., 2015). TBIs have been noted to cause long-term effects on the behaviour and the finances of the patient (Jokar et al., 2017). That is why the focus of the research is to establish the relationship between TBI use in traumatic injury and the need to use blood transfusion to help in the health situations.

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Background

Recent studies indicate significant survival rates of patients suffering from TBIs who were treated with the use of TXA (Shiraishi et al., 2017,). TXA is an analog of lysine that inhibits the activities of plasminogen. It has both the anti-inflammatory and the antifibrinolytic features. The administration of the analog has been observed to present with reduced mortality, lessened focal ischaemic lesions and decreased growth of haemorrhage (Jokar et al., 2017). The effects of TXA administration have been noted to have the equivocal and minimal impact on the progression of the TBI and the ICH despite its functions of reversing coagulopathy. Nonetheless, Maegele (2018) argues that Tranexamic acid is mostly used in the sophisticated healthcare systems due to its lower costs, efficacy in use and minimal side effect profiles

Studies have been done to determine the post-injury inflammatory and coagulopathy cases using the murine model's traumatic brain injuries (Roberts et al., 2017). The TBIs that have been associated with concomitant haemorrhagic shock have also been included in the study. The administration of the lysine analog could reduce both the cerebral and the systemic post-traumatic stress. Additionally, Joker et al., (2017) argues that haemorrhagic shocks, TBIs also exaggerate the inflammatory effects that occur in the systemic blood flow. The haemorrhagic shock that results from TBIs has been noted to result in the release of the pro-inflammatory factors that might include the cytokines (Maegele, 2018). The administration of the TXA has been established to determine the relationship between haemorrhage and TBIs to determine whether the administration of the analog can truly help in the reduction in the chances of conducting blood transfusions to individuals suffering from the injuries.

Tranexamic acid has shown the ability to reduce the inflammatory responses among the paediatric patients suffering from the cardiovascular diseases (Fulkerson et al., 2015). It has been noted that TXA can be helpful in modulating lung injuries in post-trauma. According to the study by Joker et al., (2017), there is a clear view that the TXA can be beneficial in controlling all the incidences of haemorrhage and thus reduces the need for blood transfusion. Tranexamic acid has not been noted to have modulatory effects on either the TBI or the TBIs that are associated with haemorrhage.

Tranexamic is the medication used in the prevention or treat excessive loss of blood from the body that results from post-partum bleeding or significant traumas (Mahmood et al., 2016). The analog also prevents excessive blood loss as a result of heavy menstruations, removal of teeth and nose bleeding. It has been noted that TXA is also useful inherited angioedema (Williams-Johnson et al., 2010). Tranexamic can be introduced into the body through injections or through oral routes (May 2017). The side effects of the usage of the analog are rare. Some of the side effects that are aligned with it include allergy, blood clots and colour visions (Boudreau et al., 2017).

Before the administration of the lysine analog to patients suffering from the traumatic injuries that might be related to haemorrhage, it is important to note the drug interactions that are associated with its administration (Zehtabchi et al., 2014). It is crucial that the clinical officer understands the history of the patient before deciding the right drugs to use on them. The medical practitioners need to consider drugs like, sesamoid or any other type of drug that is used by the patients in the control of bleeding (Chan et al., 2017). Chemotherapeutic medications are not advised on patients who are allergic to TXA and have history of thromboembolism diseases. Ker et al., (2015) also argues that individuals with severe renal impairment due to drug accumulation are also not encouraged to take the drug if they suffer from TBIs.

Study Aim

This study aims to determine whether the use of tranexamic acid in the treatment of traumatic brain injuries can help reduce the chances of the necessity of blood transfusion

Proposed Methods

Design

The study is designed to employ a quantitative approach that will look into treatment at a single centre, which is the King Faisal Specialist Hospital and Research Center. The single treatment design will be used for multiple patient participants who meet inclusion criteria. The sampled patients at the hospital's ED shall be enrolled in the research by continuous sampling until the target of 1000 is achieved. Allocation for treatment (placebo or TXA) will be done through a pragmatic, randomized, placebo-controlled design with double-blind to quantify effects TXA has on TBI patients with regards to need for transfusion (Hayes and Moulton, 2009). Employing a quantitative approach to the research would enable measurement of the effects TXA has on the patients for purposes of comparison with non-treatment (placebo) effects. A single centre use for conducting the research is for convenience purposes since the research is intended to be conducted individually. The inclusion and exclusion criteria serve to recruit participants for whom findings can be generalized thus selected based on the group for whom the treatment (TXA) is intended. Using a pragmatic, randomized technique with blinds on participants and researcher as well as controlling it with placebo non-treatment allows for findings with high validity, low bias and high potential for generalization. The research method of this study is applied in a similar way to the CRASH-3 protocol (Dewan et al., 2012).

Population of Interest

The patients will attend a pre-operative screening before any surgical intervention. Additionally, the participants to be selected for the study will be at least 16 years old. The method is essential in the determination of eligibility of the patient to participate in this research. The exclusion criteria shall be in consideration of the following: abnormalities related to coagulation or incidences of thromboembolic disease in the patient's history. The second consideration shall be cases of hypersensitivity to TXA. Thirdly, if the patient has experienced acute coronary diseases or stroke in the past three months, he/she shall not be allowed to participate. Patients with renal failure also will be left out. Those that are currently under treatment with anticoagulatory therapy also shall be left out of the study. The valid participants shall sign the consent form to allow the researchers to administer medications and possible blood transfusions necessary for the research and their health too.

Sample and Sampling Approach

The study will target 1000 adult Emergency Department patients. The people who will be allowed in the study shall have the following characteristics: they shall be adults with TBI within 8 hours of injury indicated by intracranial bleeding as shown on CT scans as elaborated in the previous discussion on the population of interest. Exclusion criteria will affect patients with significant extra-cranial bleeding since the outcome for this group is known to be improved by TXA. The patients shall get assurance that the research is committed to keeping the patients' private and personal information anonymous. The assurance will make the patients comfortable in participating in the study. Above all, the researcher shall seek the consent of the patient. The importance of this aspect is to restore the participants' confidence on the competence of the research. Therefore, the patients will be at ease to give their personal detail regarding their health matters hence ensuring the achievement of such a huge sample of 1000 participants within the allocated time frame.

Data Collection Approach

Uncertainty as to whether proposed treatment (TXA) provides best outcomes for TBI patients compared to the current medical protocol (uncertainty principle) since it will advise the inclusion criteria. Eligible patients will be randomly assigned treatment for TXA or non-treatment, a placebo, and the latter will serve as the control group. The researcher, the healthcare providers at the centre and patients will not be aware of the treatment assigned. The sampling of patients will continue until the 1000th patient after whom the desired sample will be deemed to have been achieved. Data collection will be done in an organised manner to ensure accurate entry of records. Upon discharge or death, the hospital records of participant patients shall be obtained by a researcher with permission from resident physicians within three years since patient was recruited for the study. The measure that will be applied is an estimation of appropriate treatment effects with precisions of about 95% confidence levels.

The large sample size will have a great power to influence detection in any transfusion reduction directly attributed to the treatment. Using the uncertainty principle requires the primary physician's approval due to some uncertainty over the prognosis of alternative therapy with existing procedures to be sure patient inclusion is for "intention to treat" purposes only (Dewan et al., 2012). Random assignment and blinding to limit bias can improve the validity of findings and would ensure findings are traced back to the research treatment agent only due to established cause and effect (Lewin, Glenton, and Oxman, 2009). A sample size of 1000 is large enough regarding study hypothesis to be generalized to relevant population. A review of ambulatory and hospital records is the most appropriate method to collect data for this trial since treatment effects on patients can only be collected reliably and ethically from hospital records.

Data Management and Analyses

The collected information shall be subject to quantitative methods of analysis appropriately. The data shall be subject to exploratory analysis to establish the trends and consistencies found out from the study. Only the variables with the capacity of impacting the study shall be considered, otherwise, the minimal inferences shall be statistically ignored to determine the major variables. Appropriate descriptive statistics will be used to summarize data of individual variables, considering each variable's level of measurement and the observed distribution of its data. A p-value with a significance of <0.05 shall be employed in the analysis. The percentages will be used to indicate the extent of concern of each variable and their differences recorded for easy interpretation of the results. The t-test shall be useful in the analysis of the distribution characteristics of the information....