Brain Bleed Outcomes Improve With Bundled Care Strategy

So what?

 So no reporting or measurement of 100% recovery, obviously not important to the medical staff or researchers. But vastly important to stroke survivors. 

“What's measured, improves.” So said management legend and author Peter F. Drucker 

The latest bad research here;

Brain Bleed Outcomes Improve With Bundled Care Strategy

Positive results from combining BP, glucose, fever, anticoagulation control

by Nicole Lou, Senior Staff Writer, MedPage Today May 25, 2023

Bundling early blood pressure (BP) lowering with other simple medical interventions produced clinical benefits in acute intracerebral hemorrhage (ICH), according to the large INTERACT3opens in a new tab or window trial conducted in lower income countries.

Bundled care improved functional recovery at 12 months, with 14% lower odds of worse functional outcome score compared with the usual care group (common OR 0.86, 95% CI 0.76-0.97).

The proportion with a good functional outcome (modified Rankin scale [mRS] score of 0-2) was 46.3% with the care bundle compared with 42.7%, reported Craig Anderson, MD, PhD, of The George Institute for Global Health and University of New South Wales in Sydney, Australia, and colleagues writing in The Lancetopens in a new tab or window.

The intervention also reduced 6-month mortality risk (OR 0.77, 95% CI 0.63-0.95), according to their results, which were also presented at the European Stroke Organization Conference in Munich, Germany.

"To our knowledge, this is the first phase 3 multicenter randomized controlled trial to show a positive outcome for an acute treatment of intracerebral hemorrhage," the researchers wrote.

While ICH is far less common than acute ischemic stroke, these brain bleeds carry a higher mortality risk.

"Moreover, the absence of a proven medical or surgical treatment for intracerebral hemorrhage has resulted in an absence of urgency to treat these patients and a low threshold for the withdrawal of active care in these patients, which contrasts sharply with modern systems of care for patients with acute ischemic stroke," Anderson and colleagues wrote.

Ten years ago, these researchers had failed to show a reduction in 90-day death or disability with intensive BP lowering alone as an ICH intervention in the INTERACT-2 trialopens in a new tab or window.

In INTERACT3, the bundled ICH intervention comprised:

• Early intensive BP lowering to a systolic target of 140 mm Hg or less
• Rapid correction for hyperglycemia, with a target 6.1-7.8 mmol/L (110-140 mg/dL) in those without diabetes and 7.8-10.0 mmol/L (140-180 mg/dL) in those with diabetes
• Anti-fever treatment to maintain a target body temperature ≤37.5°C (99.5°F)
• Rapid reversal of warfarin-related abnormal anticoagulation (target international normalized ratio <1.5)

"Time is critical when treating this type of stroke, so we tested a combination of interventions to rapidly stabilise the condition of these patients to improve their outcomes," Anderson said in a press releaseopens in a new tab or window. "We estimate that if this protocol was universally adopted, it could save tens of thousands of lives each year around the world."(But what about 100% recovery? How are you accomplishing that? The only goal for stroke survivors is 100% recovery!)

The relative contribution of each component in the care bundle on ICH outcomes will be determined in an upcoming mediation analysis, his group said.

INTERACT3 was a large international trial conducted in Brazil, Chile, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Vietnam.

Participating hospitals lacked a pre-existing ICH-specific protocol and were willing to implement the care bundle to consecutive adults with imaging-confirmed spontaneous ICH presenting within 6 hours of stroke onset. Key patient exclusion criteria included ICH secondary to a structural abnormality in the brain or to reperfusion therapy.

The trial randomized groups of hospitals in a stepped-wedge, cluster design to the order in which they were to switch from usual care to intervention implementation.

Ultimately, the modified intention-to-treat population included 7,036 patients enrolled at 121 hospitals. Mean age was 62 years, 36% were women, and over 90% were Chinese. Median Glasgow coma scale and NIH Stroke Scale scores were 12 and 13, respectively. The cause of the ICH was presumed to be related to hypertension in 94.3% of people, and it was located deep in a cerebral hemisphere in 82.3%. Hemorrhage volumes reached a median 15.0 mL.

Functional recovery in the trial was assessed by blinded research staff.

Study authors reported that the relatively favorable distribution of mRS scores after bundled care was generally consistent across various sensitivity analyses (e.g., additional adjustments for country and patient variables) and with different approaches to imputing missing data.

Secondary endpoints of mortality, health-related quality of life, and time to discharge also significantly favored the care bundle group.

Bundled care patients also suffered fewer serious adverse events than did the usual care group (16.0% vs 20.1%, P=0.0098).

Anderson's group acknowledged the considerable heterogeneity in success recruiting patients across sites and the trial's disruption by the COVID-19 pandemic.

Even so, they pointed out that the "large sample size allowed for the detection of a modest, but still clinically worthwhile, benefit that is generalizable, because an ethnically and sociodemographically diverse population was included from different resource settings."

"A lack of proven treatments for ICH has led to a pessimistic view that not much can be done for these patients. However, with INTERACT3, we demonstrate on a large scale how readily available treatments can be used to improve outcomes in resource-limited settings. We hope this evidence will inform clinical practice guidelines across the globe and help save many lives," said study co-author Lili Song, MD, PhD, also of The George Institute, in a statement.

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  Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow

Disclosures

INTERACT3 was supported by the U.K. Department of Health and Social Care, the Foreign, Commonwealth & Development Office, the Medical Research Council, and the Wellcome Trust; the West China Hospital Outstanding Discipline Development program; Australia's National Health and Medical Research Council; Sichuan Credit Pharmaceutical; and Takeda.

Anderson has received grants from the National Health and Medical Research Council and Medical Research Futures Fund of Australia, the Medical Research Council of the U.K., Penumbra, and Takeda China; is also the chair of the data and safety monitoring boards for several trials; is a board member of the World Health Organization; and is the editor-in-chief of Cerebrovascular Disease.

Primary Source

The Lancet

Source Reference: opens in a new tab or windowMa L, et al "The third intensive care bundle with blood pressure reduction in acute cerebral haemorrhage trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial" Lancet 2023; DOI: 10.1016/S0140-6736(23)00806-1.