A US-wide clinical trial has provided doctors with new insights into the importance of managing stroke patients’ blood sugar after treatment with clot-busting therapy.
The findings, from research led by researchers at the University of Virginia Health System (UVA Health), could help improve stroke care and save lives.
The SHINE trial was conducted at UVA Health and 69 other hospitals around the country.
The new analysis of the trial results, led by UVA Health’s Andrew Southerland, MD, found that high blood sugar shortly after thrombolysis – opening blocked arteries in the brain with a clot-busting drug – was associated with greater risk for potentially deadly brain bleeds, particularly in older patients with more severe strokes.
These brain bleeds, known as symptomatic intracerebral haemorrhages, are considered one of the most dangerous complications of ischemic stroke treatment.
Southerland is a stroke expert at UVA Health and the UVA School of Medicine.
He said: “This is the first large-scale prospective clinical trial in stroke patients to provide data on the post-treatment effects of high blood sugar on the risk of symptomatic intracerebral haemorrhage with thrombolysis.
“These data suggest that more focus and research is needed on the management of high blood sugar in the treatment of stroke patients, particularly those with higher risk, more severe strokes.”
The trial results also suggested that intensive efforts to normalise blood sugar by aggressively administering insulin after thrombolysis was not associated with reduced risk for one of these brain bleeds.
However, the researchers say that more research is needed before they could rule out the potential benefit of early insulin administration, as it may help with a “cascade of tissue injury” that can trigger an intracerebral haemorrhage.
Of the 1,151 SHINE trial participants, 725, or 63 per cent, underwent thrombolysis.
Slightly more than half were men, and the median age was 65. Approximately 80 per cent had type 2 diabetes.
Of these patients, 372 were randomly assigned to receive intensive insulin treatment, while 353 received the standard sliding scale treatment.
After adjusting for variables that could influence the results, the researchers found that the intensive insulin treatment regimen used in the trial did not appear to make a difference in the risk for intracerebral haemorrhage.
They did find, however, that in the first 12 hours after thrombolysis, every 10 mg/dL increase in median blood sugar increased the odds of intracerebral haemorrhage by 8 per cent.
In addition, how long it took patients to achieve a normal blood sugar also appeared to make a difference – patients who reached a lower blood sugar (less than or equal to 180 mg/dL) sooner typically fared better.
In general, high blood sugar after thrombolysis was associated with a greater risk for a brain bleed and with poor outcomes overall, particularly in the early post-treatment period, the researchers report.
Southerland said: “One of the most important things patients can do to decrease their risk of stroke, particularly among diabetics, is work with their doctors and lifestyle to manage their blood sugar.
“The SHINE trial suggests that we as providers need to have a similar concern for high blood sugar after stroke treatment as we do already with other risk factors, such as high blood pressure.”
Southerland and his colleagues say that additional research is warranted to better understand how best to manage patients’ blood sugar after thrombolysis, particularly for patients who suffer more severe strokes.
That research, they say, could improve outcomes and reduce the risk of intracerebral haemorrhages.
Southerland said: “We hope that these results will help inform future clinical trials looking at the treatment of blood sugar in higher risk patients with more severe strokes, particularly those undergoing clot removal procedures.
“It is exciting to be able to lead this research here at UVA, where we can work to improve stroke outcomes for our patients locally while helping move the field forward worldwide.”
