The Association is strongly of the view that as much of the practice of medicine (and particularly our specialty, Emergency Medicine) should be as evidenced-based as possible and recognises the importance of Irish input into the creation of the necessary evidence base. While it is important that interventions that have a positive outcome are studied and the benefits of the intervention are communicated to the broader medical community, it is equally important that interventions that are either not helpful or cause unnecessary risks to patients are identified and removed from practice. The recent confirmation that Tranexamic Acid [TXA] which has been used to treat upper gastrointestinal (GI) bleeding does not improve outcome but increases side effects is one such example of the latter.
Cork University Hospital (CUH) was among 164 hospitals across 15 countries to recruit patients who were suffering from bleeding from peptic ulcers, dilated oesophageal veins and upper GI cancer presenting to the Emergency Department into the HALT-IT trial. This recently released clinical trial of 12,000 patients with severe gastrointestinal bleeding which was published in the Lancet showed that TXA (which stops blood clots from breaking down) failed to cut bleeding deaths but also caused unwanted clots in the legs and lungs and excess seizures. Dr. Conor Deasy, Consultant in Emergency Medicine at CUH and Principal Investigator for the trial in Ireland, stated that ‘the study highlights the importance of robust clinical trials for patients presenting to Emergency Departments with emergency conditions so that we can be sure the treatments we administer work. Although it is often assumed that a treatment that works in one bleeding situation should work in another, these results highlight the need for clinical trials that target specific causes of bleeding.’
Gastrointestinal (GI) bleeding, from peptic ulcers, dilated oesophageal veins (varices) and cancer, is a common medical emergency that causes hundreds of thousands of deaths worldwide. Patients can either vomit blood or pass blood in the stools and up to 10% of affected patients will die. Some patients stop bleeding only to start bleeding again a short while later and these patients have particularly high death rates. Treatment includes blood transfusion and emergency surgery to tie off the bleeding vessels. TXA has been shown to reduce bleeding in surgery and reduces deaths from bleeding after serious injury and childbirth – in both cases without increasing side effects. Only a few small trials had looked at the effect of TXA in upper GI bleeding but when these trials were added together, there appeared to be a large reduction in deaths with its use. For many doctors, this evidence was conclusive; indeed, many were so convinced that they refused to take part in the trial since this would mean that half of their patients would receive a placebo. However, an international group of doctors were sceptical and decided to carry out this global trial that was co-ordinated by the London School of Hygiene & Tropical Medicine. The CUH team of clinical researchers included staff in the Emergency Department, Intensive Care Unit, Surgery and Gastroenterology departments supported by the HRB Clinical Research Facility, UCC.
The HALT-IT (Haemorrhage alleviation with Tranexamic acid – Intestinal system) trial is the largest ever clinical trial in gastrointestinal bleeding. Patients were recruited from 164 hospitals across 15 countries. The results showed that TXA does not reduce deaths from stomach bleeding but increases the risk of thromboembolic events (clots in the veins of the legs that can move to the lungs). There were also more seizures with TXA. Re-bleeding rates were similar in both groups.
Dr Deasy thanked the patients and their families who consented to being recruited to this trial: ‘the results of this trial will improve the treatment of patients all over the world with this common emergency’.