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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-00897 | Other Identifier | CER-VD |
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Recruitment slow. Standard stroke patient management was changed (CT replacing MRI if NIHSS > 10). We closed the study to avoid bias (after 28 inclusions /out of 30 planned)
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In this exploratory randomized double blind placebo controled trial, lactate solution or placebo will be administered to acute ischemic stroke patients selected for endovascular treatment (EVT) without intravenous thrombolysis. The treatment will be administered within one hour after EVT. Primary outcome measures will be lactate and metabolite concentrations in the ischemic lesion, in the penumbra and contralaterally, evaluated by magnetic resonance spectroscopy(MRS). Secondary outcome measures will be evolution of the ischemic penumbra, clinical outcome at 3 months.The trial will end when 10 patients per group have completed the study.
This is an exploratory randomized double blind placebo controled trial on acute ischemic stroke patients. Lactate solution or placebo will be administered to acute ischemic stroke patients selected for endovascular treatment (EVT) without intravenous thrombolysis. Magnetic resonance spectroscopy will be performed before EVT to measure metabolite concentrations in the ischemic core, penumbra and in the contralateral hemisphere. The treatment will be administered within one hour after EVT. As soon as the patient is stabilized, she/he will undergo an additional magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS). MRS will also be performed during the control MRI after 24 hours. Neurological deficits will be evaluated on admission, at 24 hours using the National Institute of Health Stroke Scale (NIHSS), and at 3 months, with both NIHSS and the modified Rankin scale. Primary outcome measures will be lactate and metabolite concentrations changes in the ischemic lesion, in the penumbra and the contralateral side, evaluated by magnetic resonance spectroscopy after intervention compared to baseline MRS values. Secondary outcome measures will be evolution of the ischemic penumbra and clinical outcome at 3 months. The trial will end when 10 patients per group have completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | patients will be injected with placebo |
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| Lactate | Active Comparator | patients will be injected with lactate solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactate | Drug | Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Does the administered lactate reach the brain | Measurement of lactate and other metabolites in lesion, penumbra, contralateral side using magnetic resonance spectroscopy measured after intervention and compared to baseline values. After intervention, the MRS will be performed as soon as possible considering that these patients have an EVT under general anesthesia and need to be stabilised after the EVT and study treatment intervention before the MRS. | Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours) |
| Does the administered lactate persist in the brain at 24 hours | Measurement of lactate and other metabolites in lesion, penumbra, contralateral side using magnetic resonance spectroscopy measured at 24 hours and compared to baseline values. | The MRS will be performed during the routine clinical MRI approximately 24 hours after EVT |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of lactate on neuronal death after intervention | Assessment of N-acetyl aspartate (NAA), a neuronal marker, using MRS and compared to baseline values, in the ischemic core and in the ischemic penumbra. | Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenz Hirt, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUVaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
Individual patient data will be made available 1 year after the end of the study to other investigators if the patient provides informed consent for further use of his/her data.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019344 | Lactic Acid |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Numbered vials, prepared by hospital pharmacy
| Placebo |
| Drug |
Intravenous injection (20 min) |
|
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| Effect of lactate on neuronal death at 24 hours |
Assessment of N-acetyl aspartate (NAA), a neuronal marker, using MRS and compared to baseline values, in the ischemic core and in the ischemic penumbra. |
| Measurement at during the routine control MRS, approximately 24 hours after EVT |
| Effect of lactate on evolution of lesion at 24 hours | Assessment of lesion using diffusion weighted Imaging (DWI) compared to baseline value | At 24 hours |
| Effect of lactate on evolution of penumbra at 24 hours | Check impact of intervention on the penumbra using perfusion weighted imaging (PWI) at 24 hours compared to baseline | This evaluation will be based on the routine MRI evaluation performed approximately 24 hours after EVT |
| Clinical outcome at 24 hours | Evolution of the neurological score (NIHSS) and compared to baseline assessment | at 24 hours |
| Clinical outcome at 3 months | Evolution of neurological score (NIHSS) compared to baseline value | Measurement at follow up (3 months) |
| Handicap at 3 months | Evolution of neurological handicap (mRS) compared to baseline value | Measurement at follow up (3 months) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |