Surgical management in treatment of Jehovah's witness in trauma surgery in Indian subcontinent.

The Jehovah's Witness religion is a Christian movement, founded in the US in the 1870s, with 7 million followers worldwide with only 0.002% in India. There is minimal to complete absence of awareness about the existence of this community in our society. Astonishing is that fact that among medical professionals, there is almost no awareness about this unique population, regarding the fact that they completely refuse of blood transfusion even if it leads to their death. This is integral to their faith. Besides legal and ethical issues in treating these group of patients, the biggest challenge exist even in the western world is their management in trauma scenario where few options exist. We have discussed the issues and recommendations in management in trauma scenario in our Indian subcontinent.

“The one thing you must not eat is meat with blood still in it; I forbid this because the life is in the blood.”

Based on these words from Genesis, 9:2-4 and many other passages from the Bible, the refusal of blood transfusion or blood products even when their life is at stake by Jehovah's Witnesses (JW). Their belief in “Holiness,” which means to “set apart” from the world, is essential to their faith.[1] There has been extensive literature published in respect to ethical issues and in other elective surgical procedure of JWs. During the literature search, we came up with very few articles published which proposed an acceptable methodology in managing these patients in trauma scenario. There was no definitive strategy mentioned in managing these patients in trauma settings. The trauma surgeons still face a daunting task in managing such patients and faced with conflict between religion and medical ethical dilemma.

INDIAN SUBCONTINENT ISSUES

In our multicultural society of India, with population over billion people, there is little awareness about the faith of this small community even among the common man. Currently, out of their 7 million followers worldwide,[2] their percentage out of this is only 0.002% in India.[3] We are unable to verify the authenticity of this information. Due to scarcity of advanced medical facilities, this shall be the biggest challenge in our changing country in the coming times to manage this group of patients. Its explosive situation since, in remote areas people still lack basic helath facilities leave alone managing a patient where blood transfusion is not an option. Majority of the cases, to best of our knowledge, JWs reside in the cities where tertiary care medical facilities are available if not for all.

ETHICAL ISSUES AND LEGAL ISSUES

Recent literature suggests that a change in the perception to treatment of JW is changing due to advancements in technology and awareness of legal principle of informed consent. The verses of Bible though not mentioned in medical terms, JW perceive them as ruling out transfusion of whole blood, packed red blood cells, plasma, white blood cells, and platelets administration. Many of the followers do allow use of (nonblood prime) heart-lung dialysis, or similar equipment if extracorporeal circulation is uninterrupted. A standard practice for treating such patients has been developed that suffices in treating the “whole person.”[4] Majority of legal battles have reinforced the patient rights of individual autonomy for accepting their treatment, even when the decision may not be medically acceptable.[5] The blood transfusion among JW against their wishes even as a life-saving procedure has caused postoperative psychosocial outcomes like depression, guilt, and this may persist for many years.[67] The United Nations convention on the Rights of the Child released in November 1989, implemented in 1990 has clearly emphasized the fact that children need special care, assistance, and protection because of their vulnerability.[8]

ACCEPTED AND REFUSED BLOOD COMPONENTS AND PROCEDURES

Among the refused blood components are whole blood erythrocytes, platelets, fresh frozen plasma, cryoprecipitate, granulocytes, and predeposited autologous blood.[9] The usually acceptable products are normovolemic haemodilution, intraoperative red blood cell salvage, erythropoietin, hemodialysis, cardiopulmonary bypass, veno-veno bypass. Individual decision (“conscience item”) includes albumin, immune globulins, and factor concentrates organ and tissue transplants.

CURRENT POLICY AND PRACTICE OF WATCHTOWER AND BIBLE TRACT SOCIETY ON PROHIBITED AND ACCEPTABLE TREATMENT

The current policy of Watch Tower Society (WTS) does not prohibit the use of albumin, immuno globulins, and hemophilic preparation in many cases.[10] This depends on individual perception and personal wishes.[10] Shanders[11] has taken position to remain silent on religious issues and focusing purely on clinical concerns because this may be an attempt to religious conversion. Preapproval of use of hemoglobin-based substitutes in JW patients has already been published in newspaper accounts (Sacramento Bee, August 24, 2000, CA, USA).[111213] Clinical accounts of the same substitutes have also been published.[111213] A 16-year experience of treatment and transfusion dilemmas at level I trauma center reported by Nelson et al.,[13] recommended the standard use of Advanced Trauma and Life Support history be augmented to include patient's beliefs. They also concluded the routine use of H-2 blockers therapy as reasonable protocol in all seriously injured JW regardless of the initial hemoglobin. Transfusion rate for injured has been reported in literature, between 5% and 7%, and major changes in therapeutic planning were also performed in 13% of JW cases.[1314] This may represent the patient's personal choice and is not a reflection of any standard policy of JW or WTS. There is interpatient variability regarding the viewpoints on these products and procedures.[15] Use of hetastarch,[16] large dose intravenous iron dextran injections,[1718] Fluosol DA[19] and the sonic scalpel[20] are promising and are not against religious beliefs of JW. However, large volumes of hetastarch may have adverse effect on coagulation.[21] All these products are available at limited centers in India and may not be accessible to every JW. The government of India needs to be informed about their and personal needs and better communication between the health care authorities and patient.

CHALLENGES FACED IN TRAUMA SURGERY FOR JEHOVAH'S WITNESSES

Trauma surgeons are faced with a unique and most challenging clinical scenario in preparing the management of such scenario. Familiarity of such situation may differ from different trauma centers and needs experience in treatment planning. Mechanism and type of injury, severity of injury and age of the patient are important predictors in the outcome. There is no literature suggesting the role of gender in the outcome of these groups of patients. The first priority is rapid hemostasis stabilization. Therefore, the resuscitation begins at the scene and emergency department and the delay in treatment should be reduced.[22] Finfer et al Fir et al.,[23] and Rupp et al.,[24] described JW patients with lower hemoglobin levels and compared the injury severity of patients who survived without blood transfusion after trauma. This study included younger patients and can not be applied in general. Successful management of young JW with massive traumatic blood loss has been reported.[25] Similar to the work of Ott and Cooley,[26] a retrospective review of the risk of death for JW after major trauma concluded that after controlling for age, race, systolic blood pressure, Glasgow Coma scale score, and the type of trauma, JW patients have no significant risk of death after major trauma compared with other religious groups.[27] In this particular study, when compared with demographic and injury variables JW were likely to die than non-JW after major trauma. Even after extensive search of literature, there is no concrete evidence that transfusion in a massive trauma is ideal or life-saving.

BLOOD MANAGEMENT STRATEGY FOR JW IN TRAUMA

The issue of transfusion is integral to the entire management to trauma, because the challenges vary from a hemodynamically stable patient to hemodynamically unstable patients. This knowledge is critical to surgical decision even in a hemodynamically stable patient. Good outcomes following emergency treatment in JW who were anemic have been reported by few outcome studies.[28] Major cardiac[26] and other elective surgery[2930] have been successfully performed in JW. But trauma surgery has its own limitations. Blood substitutes are good alternative to standard blood transfusion for JW and can provide adequate oxygen carrying capacity until the bone marrow compensates for the loss for red cells.[3132] Although the optimal dose of erythropoietin in a critically ill patient remains to be established, the empirically chosen high dose by some studies shows rapid response[3334] and suggests therapy with erythropoietin and polyHeme particularly useful in critically ill JW.[33] Berend and Levi[34] suggested that in emergency scenario without blood card and with out sufficient time or advance directives blood can be transfused with out delay to save patient's life. This in accordance with the Health Care Consent Act, 16 which states that “a treatment may be given without consent in an emergency” if, in the opinion of the physician, there is no means of communication with the patient and if the delay might place the patient in sustaining serious bodily harm. However, in majority of the cases patients have their blood card and advance directive with them which again brings the doctor back to the same dilemma.

PREOPERATIVE BLOOD SALVAGE STRATEGY

Use of pediatric venepuncture kit: helps in saving preoperative blood loss but its clinical significance and outcome in a trauma setting is unknown.

Whole blood gas analyzer: used to measure arterial blood gases arterial blood gases, electrolytes, and glucose on daily basis.[34] Reducing the frequency of testing and the size of the sample tube, point-of-care diagnostic technologies,[35] and use of noninvasive and invasive oximetric techniques have been successfully implemented.

Coagulation profile: Our main concern in trauma situation is the elderly, pediatric population, and patients with concurrent comorbid conditions like cardiopulmonary disease, anemia, renal disease, and coagulation defects. Cardiovascular ischemia may occur if hematocrit (Hct) decreases below a critical point (Hb 3-5 g/dL).[36] Young patients tend to better despite the extremely deranged variables like Hct.

Conflicting evidences

Death after trauma in previously healthy JW patients is similar to those of other religious groups even after refusing blood transfusion.[37] The initial benefits of transfusion may be beneficial in most of the non-JW patients if not all and differs from one clinical scenario to another. In a retrospective analysis of patients who refused a blood transfusion for religious reasons,[38] those with a Hb of 4-5 g/dL had a 34.4% mortality rate and a 57.7% rate of serious side effects, such as myocardial infarction, arrhythmia, and cardiac failure. For every 1 g/dL reduction in Hb from 8 g/dL, the incidence of side effects increases 2.5 times. When Hb drops below 5-6 g/dL, the patient is at the highest level of danger. In healthy subjects, the terminal Hb is precisely not known, but usually below 5 g/dL or as low as 3 g/dL.[3940] Survival after surgery with Hb range of 2.2-3 in JW has been reported with postoperative hemoglobin as low as 1.4 g/dL.[41] These are mere few cases and we cannot follow any specific guidelines based on them, especially in our Indian set up.

METHODS OF REDUCING INTRAOPERATIVE METHODS OF BLOOD LOSS

General precautions

Obtaining immediate homeostasis, meticulous surgical technique, length of surgery,[42] intraoperative autologous, fibrin and thrombin plugs, isovolemic hemodilution, and protease inhibitors (may or may not be accepted by the patients), use of tourniquet without intraoperative deflation technique to control intraoperative hemostasis. It has also been suggested that tourniquet release for hemostasis may actually increase the rate of bleeding.[43]

Specific measures for JWs

The administration of alpha recombinant erythropoietin has shown to increase in reticulocyte count and Hct levels. The administration can be done subcutaneously and does not require intravenous access. This is a slow process and may be beneficial for postoperative recovery duration and urgent treatment.

Another technique is induced hypotension by which blood loss can be controlled.[384344] The risk of deep vein thrombosis with this technique has shown no significant difference in incidence.[45] This method is often impractical in trauma patients, already hemodynamically uncontrolled, and requires aggressive resuscitation. The exception to this scenario is the hypotensive patient who has suffered penetrating torso trauma.[45] In such a situation; this technique may improve the outcome until the definitive control of bleeding is achieved.

Most JW do not allow use of fresh frozen plasma or cryoprecipitate or platelets. In such a scenario, use of pharmacological aids such as the serine protease inhibitor, aprotinin; lysine analogue anti fibrinolytics such as epsilon aminocaproic acid and traxenamic acid[757677] DDAVP; recombinant factor VIIa (rhEPO) may be a good substitute in individual cases.[46] rhEPO has been used to increase preoperative Hct for routine postoperative patients and reduce transfusion requirements in severely injured JW.[47]

In neurosurgical trauma, the plan of care does not change much regardless of the patients‛‛ beliefs,[48] since morbidity and mortality reported is no higher than those of the control group in neurosurgical cases associated with trauma.[48] Rather JW patients as a neurosurgical candidate seems to do better than non-JW who received transfusion; indicating that neurosurgical tissues tend to do better with gentle handling of the tissues and immediate meticulous hemostasis than with blood transfusion.[48]

Use of temporary partial intrailiac balloon occlusion: for temporary treatment of acetabulum fractures in JW patients seems to be a promising alternative treatment in hemostasis control.[49] Such procedures have its own limitations and risks associated like thrombus formation, catheter dislocation, vessel dissection, or rupture and hemodynamic ischemia and balloon rupture have been occasionally reported in the literature.[5051] This technique has been successfully used in JW patients undergoing total knee arthroplasty or revision hip arthroplasty to prevent blood loss.[52] The incidence of complications associated when using balloon occlusion lies between 0% and 15%.[53] Additional studies are required to confirm the viability, safety, and reliability of this procedure in various cohorts of patients.

Electrolytes are ineffective volume expanders-Fluosol-DA Blood substitute, such as Fluosol-DA 20% has promising results for providing adequate oxygen carrying capacity in JW.[54555657] Due to limited half life and lack of other attributes of whole blood, still may be inadequate in management of trauma patients.[57] One case report published describes nonoperative management of an 18 years old a splenic tear in JW patient with hemophilia[58] following blunt abdominal trauma.

Another technique, comprising of intraoperative of blood using “cell saver” autologous recirculated transfusion has been effective in JW and the WTS has not forbidden this practice, rather its matter of personal choice.[567891011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859]

Fluid administration and transfusion-related complications

Large amount of electrolyte infusion may predispose to pulmonary odema.[54] The elevation of blood pressure to per injury levels after excessive fluid administration in the presence of uncontrolled hemorrhage may even increase blood loss and mortality.

It was demonstrated that blood transfusion was associated with increase risk of development of acute respiratory distress syndrome and further aggravates mortality, having a dose-dependent affect.[60]

Length of time the products are being stored or in other words the age of the blood products: Stored blood may even harm tissue consumption of oxygen in critical patients.[6162] There is evidence in literature to suggest that there is increased rate of infection associated with transfusion of old blood after severe injury.[63] This raises the question of efficacy of such products in trauma settings to achieve satisfactory outcome. Since the storage time of such products tends to differ from one center to another, the beneficiary effects of transfusion in multiple trauma can be argued upon. More research needs to be done to have definitive answer regarding this issue and currently the benefits of transfusion as life-saving treatment, in a rapidly dropping Hct in a non-JW patient outweighs such argument.

Safety issues related to transfusion avoidance methods: With current data available, the authors have found that transfusion avoidance technologies were quite safe and incidences of severe complications were rare. No study so far has reported any pulmonary or systemic hypertension during resuscitation of the injured patient with polymerized stroma-free hemoglobin.

MANAGING PEDIATRIC POPULATION AMONG THE JEHOVAH'S WITNESSES

Care of minors in trauma situation warrants the greatest concerns among trauma surgeons and has also been matter of legal debate. The developing autonomy of mature minors is gaining recognition in medical decision making[64656667] and has the capacity to make medical decisions including those about life-sustaining situation.[68] This is in accordance with the concept of treating as “whole person,” not overlooking the possible psychosocial damage of an invasive procedure that violates family's fundamental beliefs. Often large centers around the country having experience with the JW now accept patient transfers from institution unwilling to treat witnesses, even pediatric cases. Luciana et al.,[68] reported a case of the care of a JW child with multiple trauma and severe anemia treated successfully without transfusion despite very low Hct.

COST OF THE ALTERNATIVE TREATMENT IN SUCH PATIENTS AS COMPARED TO CHEAP BLOOD PRODUCTS

Fergusson et al.,[69] concluded that, with exception of preoperative autologous donation, there was evidence that individual modalities used in appropriate settings were associated with cost savings. Many blood conservation methods are more dependent on technique than technology. Some techniques have the ability to manage cost-effectively clinical situations without the allogenic transfusion for example in case of cell salvage technique. This may be true for elective surgery but a trauma scenario is very different. There are no data available to currently assess the difference in the cost management between the two completely different clinical situations. There is conflicting evidence to suggest that the cost of managing patients with conservation methods is equivalent to or less costly than standard care. Tratter et al.,[70] also reported a similar assessment in patients requiring gastrointestinal surgery and reported that the incidence of postoperative infections, hospital charges of patients receiving conventional allogenic transfusion was higher compared with standard care given. Contrary to this, similar to the findings of Woodings[71] Doyle[72] concluded that the postoperative care in intensive care unit of such patients is huge financial burden and such an expenditure of resources could be used to provide warranted medical intervention to a large no of patients. Arguably, the quality of care cannot be compromised by the financial issues alone and this still remains an issue of debate [Table 1].

Table 1

Treatment flow chart

PRACTICAL ISSUES AND FUTURE GOALS

As much as expected from the doctors to respect the beliefs and faiths, there should be an attempt in every situation to examine carefully as to what is unacceptable for some may be acceptable to the other.[7374]

In a trauma scenario this may not be entirely correct. Due to the limitations of time and resources, this is a matter of grave concern regarding clear guidelines in management of JW in trauma surgery. Past 15 years of literature review shows advancements in elective surgery in various fields and has described various modalities of treatment for JW. Little technological advancement has been done in managing JW patients in trauma situation. With enough evidence of risks associated from routine use of blood products for transfusion itself, more needs to be done to deal with these problems not only for JW but also for non-JW patients. Finally, trauma itself is unique situation and further making it complex are such situations. Despite so many years of struggle in searching for an alternative treatment, in trauma scenario, there still exits no definitive or live saving treatment among these patients. In conclusion, there is wide scope for further study to be done to come out with an affirmative answer to this unique situation. Blood transfusion in majority of cases may still remain a life-saving option but not free from complications. However, respecting others religious beliefs and individual autonomy in decision making regarding his or her treatment is also of paramount importance and above any medical ethics or clinical judgment.[98]