Abstract
Please note that this case is entirely fictitious. Any similarity to a clinical trial being carried out by the British Army or armed forces of any country is entirely coincidental. To the best of our knowledge, no such trial is being carried out. However, the history of HBOCs and their risks is well documented.
The British Army has submitted a request for ethical approval for a study into a blood substitute to be used in place of saline solution in trauma victims in combat situations.
In trauma incidents where a casualty has lost a lot of blood and is at risk of death from loss of blood volume, the standard treatment is to infuse saline solution to increase blood volume and so stabilize blood pressure until the casualty can be admitted to a clinical facility where they can be transfused with blood and have their injuries treated surgically. For many decades there has been research into the safety and efficacy of blood substitutes known as HBOCs (haemoglobin-based oxygen carriers). The hope with HBOCs is that because, unlike saline, they oxygenate the blood they can prevent deaths caused by lack of haemoglobin before the casualty can be administered blood in a hospital environment.
However, research into HBOCs has been mired in ethical controversy. Research so far has showed no significant improvement in mortality and, in some cases, has resulted in an increase in mortality and adverse reactions (such as a dangerous increase in blood pressure and suppression of cardiac function). Most of these studies have been conducted in the USA, and the FDA has so far refused regulatory approval for any HBOCs.
Some of these studies were been conducted on civilian trauma patients where permission was given to waive the requirement for informed consent. Given the condition of people suitable for administration of an HBOC – severe trauma with life-threatening blood loss – it is not possible to gain informed consent to administer an HBOC rather than the standard saline solution at the point at which the decision needs to be made. Instead, trauma units signed up to take part in the study and public information events were organized to inform the public within the area served by a trauma unit about the study and provide them with the opportunity to acquire a wristband that refused consent for the use of an HBOC in the event a person became a trauma victim. But there was significant doubt that people were aware of the study and so had an opportunity, via the use of a wristband, to decline to participate.
Furthermore, some patients were not simply administered an HBOC instead of saline prior to hospital admission in order to stabilize them but continued to be treated with an HBOC rather than blood (the established treatment) on admission, which it is thought contributed to the increased mortality and adverse reactions.
The Army will be trialling a new generation of HBOC that it is hoped will overcome the problems of previously tested HBOCs. The trial will take place at the British Army’s field hospital facility in Afghanistan which deals with a significant number of serious injuries caused by IEDs resulting in multiple limb loss, and where the treatment provided in the field before the casualty can be transported to the hospital can mean the difference between life and death. Given the circumstances of a war zone there can often be a considerable delay between the blast which causes life-threatening injury and the admission to the clinical facility where the injuries can be treated, increasing the risk of death due to blood loss. The proposal is to use the HBOC rather than saline only until the casualty reaches the hospital in order to stabilize them until blood can be administered.
All Army personnel likely to be in a combat situation or at risk of encountering an IED will be provided with written information about the study and, as part of their pre-deployment induction, will take part in a group information session where the study will be explained and wristbands will be available for those who wish to opt out of participation in the event of serious injury where saline would usually be administered. An opt-out decision will also be documented in their records.
Would you approve this study?
Would you require any changes prior to approval?