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Hans-Göran Hårdemark

Publications and source records attributed to Hans-Göran Hårdemark.

5 recordsLinked to original sources

NXY-059 for acute ischemic stroke.

BACKGROUND: NXY-059 is a free-radical-trapping agent that is neuroprotective in animal models of stroke. We tested whether it would reduce disability in humans after acute ischemic stroke. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 1722 patients with acute ischemic stroke who were randomly assigned to receive a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours after the onset of the stroke. The primary outcome was disability at 90 days, as measured according to scores on the modified Rankin scale for disability (range, 0 to 5, with 0 indicating no residual symptoms and 5 indicating bedbound, requiring constant care). RESULTS: Among the 1699 subjects included in the efficacy analysis, NXY-059 significantly improved the overall distribution of scores on the modified Rankin scale, as compared with placebo (P=0.038 by the Cochran-Mantel-Haenszel test). The common odds ratio for improvement across all categories of the scale was 1.20 (95 percent confidence interval, 1.01 to 1.42). Mortality and rates of serious and nonserious adverse events were each similar in the two groups. NXY-059 did not improve neurologic functioning as measured according to the National Institutes of Health Stroke Scale (NIHSS): the difference between the two groups in the change from baseline scores was 0.1 point (95 percent confidence interval, -1.4 to 1.1; P=0.86). Likewise, no improvement was observed according to the Barthel index (P=0.14). In a post hoc analysis of patients who also received alteplase, NXY-059 was associated with a lower incidence of any hemorrhagic transformation (P=0.001) and symptomatic intracranial hemorrhage (P=0.036). CONCLUSIONS: The administration of NXY-059 within six hours after the onset of acute ischemic stroke significantly improved the primary outcome (reduced disability at 90 days), but it did not significantly improve other outcome measures, including neurologic functioning as measured by the NIHSS score. Additional research is needed to confirm whether NXY-059 is beneficial in ischemic stroke. (ClinicalTrials.gov number, NCT00119626.).

Acute Disease↗

[Early thrombolysis indicated in threatened cerebral infarction. A study of 60 patients treated at Akademiska sjukhuset in Uppsala].

Results of the routine use of tissue plasminogen activator (tPA) within 3 hours of an acute ischemic stroke have been reported from the United States, Canada and Germany. Published reports from other countries and from centers using tPA within a wider timeframe are limited. 60 patients in a Swedish University Hospital were treated with i.v. tPA within 6 hours of onset of acute ischemic stroke symptoms. Two patients suffered more extensive parenchymal intracerebral hemorrhages, of which one required surgery and one died. At 3 months, 47% were independent, 35% dependent and 18% deceased. Due to the relatively low number of patients in this series, data should be cautiously interpreted, but the results are comparable to those of large randomized controlled trials and published phase 4 studies. The risk of tPA treatment after 3-6 hours does not seem to be significantly increased as compared to treatment within 3 hours.

Acute Disease↗

The impact of different spectral Doppler criteria on the proportion of high-grade internal carotid artery stenosis in patients undergoing duplex scanning.

AIM: To investigate the impact of different spectral Doppler criteria on the proportion of high-grade ICA stenosis in patients undergoing carotid artery duplex scanning. MATERIAL AND METHODS: Duplex scans of 4,548 internal carotid arteries (ICA) in 2,349 patients were retrospectively analyzed. The following different criteria were applied for each scan for definition of ICA stenosis > or = 70%: Criteria I=ICA peak systolic velocity (PSV) > 130 cm/sec and ICA end-diastolic (EDV) > 100 cm/sec, Criteria II=PSV ICA/common carotid artery (CCA) ratio > 4, Criteria III=ICA PSV > or = 230 cm/sec, Criteria IV=ICA PSV > 230 cm/sec and/or ICA EDV > or = 100 cm/sec and/or PSV ICA/CCA ratio > or = 3.2. RESULTS: The frequency of detecting a > or = 70% ICA stenosis with criteria I, II, III, and IV were 5.5%, 6.8%, 8.4%, and 9.6%, respectively (p < 0.05). CONCLUSION: The use of various duplex criteria significantly affected the number of scans receiving a diagnosis of ICA stenosis of > or = 70%.

Adolescent↗

Carotid artery endarterectomy solely based on duplex scan findings.

The purpose of this study was to review experience with carotid artery surgery based on findings obtained solely from duplex scanning with special regard to unexpected findings during surgery and the early outcome. From January 1993 through December 1999, 271 consecutive patients underwent 287 carotid endarterectomies (CEAs), 229 (80%) of which were performed solely based on duplex scan findings. During the study period 5,932 carotid artery duplex scans were performed in 4,466 patients. Of 589 patients with internal carotid artery (ICA) stenosis 70%, 246 underwent CEA compared to 25 of 156 with 50-69% ICA stenosis. The indications for CEA were transient ischemic attack (TIA) in 88 (30.7%), amaurosis fugax in 60 (20.9%), previous stroke in 91 (31.7%) and asymptomatic disease in 48 (16.7%) cases. There were no statistically significant differences between the groups operated on with and without preoperative angiography with respect to the indications for surgery, associated risk factors, or the degree of stenosis on the contralateral side. In patients undergoing surgery without angiography, there were no unexpected findings that influenced the performance of surgery, in all except 1. There were no significant differences in perioperative morbidity and mortality in patients undergoing surgery with and without conventional angiography. The combined mortality and major stroke rates were 3.4% and 2.2%, respectively. It is concluded that CEA can safely be performed without preoperative angiography in cases with conclusive duplex scan findings.

Aged↗