A large trial of high-dose blood thinners in critically ill Kovid-19 patients admitted to the hospital is being temporarily halted as there is no benefit from the treatment and little harm could be done, trial leaders announced Tuesday.
The Independent Monitoring Board, which called for the trial to be adjourned, did not announce possible damages. High doses of anticoagulants are known for uncontrolled bleeding – in places including the inside of the skull, which can be very dangerous.
Trial leaders are urgently trying to spread the word that the trial has been suspended, as some hospitals are still aggressively putting their intensive care patients on high doses of anticoagulants that outweigh the risks, while the opposite may be true.
“Because of the potential for harm, we need to make a comprehensive announcement of this break in the trial,” said Matthew D. Neil, a surgeon and intensive care specialist at the University of Pittsburgh Medical Center, who is leading one of the many teams. “Trial.
The trial teams, which have registered nearly 10,000,000 patients in some countries, will examine the data closely to see if enrollment can resume in a hearing branch focusing on critically ill hospitalized patients.
Covid-19 is widely known to produce small blood clotting groups that block blood capillaries and cause damage to the lungs, kidneys, heart, brain or other organs, as well as the fingers and toes. Dr Neil said low doses of blood thinners are routinely given to Covid-19 patients admitted to the hospital.
The branch of the trial is given to patients who are only moderately ill in doses of blood thinners.
Sick patients usually include those who receive oxygen but are not in intensive care, not on a ventilator or at risk of failure of other organs such as the kidneys.
In October, an observational study from the Journal of the American College of Cardiology found that covid-19 patients who were given blood thinners did better than those who were hospitalized with nothing. In that study, there was little difference in outcomes or negative side effects between those who received higher or lower doses.
Because of that study, many doctors assumed that if a small amount of anticoagulant was good for most patients, the weakest patients should take the highest dose, said Dr. K. Krishnan, director of the Heart Disease Prevention Center. Jeffrey S. Said the burger. Disease of New York University Medical School and another chief investigator in a suspended trial.
Dr. Berger said of new evidence that larger doses could be harmful. “It helps us understand that we don’t have all the answers.”
Anticoagulants are known for bleeding under the skin and in the gastrointestinal tract, and for wounds that do not heal when the skin is pierced.
Bleeding inside the skull is rare, but can cause permanent brain damage or death, said Dr. Burge noted.
Dr. Neil said he treated Kovid victims “with problems from both ends of the spectrum: blood clotting patients and bleeding patients.”
D trial. Neil said one goal of the trial is to determine which patients are most likely to benefit from anticoagulants.
Patients are often tested for a breakdown product of blood clotting, and C-reactive protein, a marker of inflammation that can be caused by clotting. Dr. Neil said it would be useful to know if tests could accurately predict which patients would be most helped by high doses of anticoagulants.
The paused trial is a large, integrated effort by the fact that many countries once had three different clinical trial groups. It is jointly funded by national health organizations and its partners in Canada, the UK, Australia, Australia and the European Union.
“This is a very cooperative thing with which I have been involved in medicine all my time,” Dr. Neil said.
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