“The safety of idarucizumab observed in this study supports its urgent use even if patients later prove to have had little or no circulating dabigatran,” the team concluded.
“Even in patients with severe renal insufficiency, the effects are gone within a day or two. From that point forward it’s fine to put them back on dabigatran,” Dr. Pollack said.
Clinically, the outcomes were more complicated. In the uncontrolled bleeding group, it was not possible to pinpoint when bleeding stopped in 98 cases of intracranial bleeding, or in 67 other patients.
“We know that dabigatran was reversed, we just can’t say when the bleeding stopped,” said Dr. Pollack.
The researchers were able to confirm bleeding cessation within 24 hours in 134 other patients. In the urgent surgery group, many patients received blood products. Interim results involving the first 123 patients were released in April 2016.