Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial
Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety a...
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| Published in: | Lancet neurology Vol. 15; no. 12; pp. 1228 - 1237 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
Elsevier Ltd
01.11.2016
Elsevier Limited |
| Subjects: | |
| ISSN: | 1474-4422, 1474-4465, 1474-4465 |
| Online Access: | Get full text |
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| Abstract | Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage.
MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18–80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770.
Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7–22.6] vs eight [14·8%, 6·6–27·1], p=0·542), 7 day mortality (zero [0%, 0–8·4] vs one [1·9%, 0·1–9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1–12·6] vs five [9·3%, 3·1–20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1–12·6] vs zero [0%, 0–6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0–35·6] vs three [7·1%; 1·5–19·5]; p=0·051).
MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage.
National Institute of Neurological Disorders and Stroke, Genentech, and Codman. |
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| AbstractList | Summary Background Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage. Methods MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18–80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov , number NCT00224770. Findings Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7–22.6] vs eight [14·8%, 6·6–27·1], p=0·542), 7 day mortality (zero [0%, 0–8·4] vs one [1·9%, 0·1–9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1–12·6] vs five [9·3%, 3·1–20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1–12·6] vs zero [0%, 0–6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0–35·6] vs three [7·1%; 1·5–19·5]; p=0·051). Interpretation MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage. Funding National Institute of Neurological Disorders and Stroke, Genentech, and Codman. Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage. Methods MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18-80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered withClinicalTrials.gov, numberNCT00224770. Findings Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7-22.6]vseight [14·8%, 6·6-27·1], p=0·542), 7 day mortality (zero [0%, 0-8·4]vsone [1·9%, 0·1-9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1-12·6]vsfive [9·3%, 3·1-20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1-12·6]vszero [0%, 0-6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0-35·6]vsthree [7·1%; 1·5-19·5]; p=0·051). Interpretation MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage. Funding National Institute of Neurological Disorders and Stroke, Genentech, and Codman. Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage. MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18–80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770. Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7–22.6] vs eight [14·8%, 6·6–27·1], p=0·542), 7 day mortality (zero [0%, 0–8·4] vs one [1·9%, 0·1–9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1–12·6] vs five [9·3%, 3·1–20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1–12·6] vs zero [0%, 0–6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0–35·6] vs three [7·1%; 1·5–19·5]; p=0·051). MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage. National Institute of Neurological Disorders and Stroke, Genentech, and Codman. Background Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage. Methods MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18-80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0.3 mg or 1.0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770. Findings Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9.5%, 95% CI 2.7-22.6] vs eight [14.8%, 6.6-27.1], p=0.542), 7 day mortality (zero [0%, 0-8.4] vs one [1.9%, 0.1-9.9], p=0.562), symptomatic bleeding (one [2.4%, 0.1-12.6] vs five [9.3%, 3.1-20.3], p=0.226), and brain bacterial infections (one [2.4%, 0.1-12.6] vs zero [0%, 0-6.6], p=0.438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22.2%; 95% CI 12.0-35.6] vs three [7.1%; 1.5-19.5]; p=0.051). Interpretation MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage. Funding National Institute of Neurological Disorders and Stroke, Genentech, and Codman. Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage.BACKGROUNDCraniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter evacuation followed by thrombolysis for clot removal is safe and can achieve a good functional outcome is not known. We investigated the safety and efficacy of alteplase, a recombinant tissue plasminogen activator, in combination with minimally invasive surgery (MIS) in patients with intracerebral haemorrhage.MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18-80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770.METHODSMISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA, Canada, the UK, and Germany. We used a computer-generated allocation sequence with a block size of four to centrally randomise patients aged 18-80 years with a non-traumatic (spontaneous) intracerebral haemorrhage of 20 mL or higher to standard medical care or image-guided MIS plus alteplase (0·3 mg or 1·0 mg every 8 h for up to nine doses) to remove clots using surgical aspiration followed by alteplase clot irrigation. Primary outcomes were all safety outcomes: 30 day mortality, 7 day procedure-related mortality, 72 h symptomatic bleeding, and 30 day brain infections. This trial is registered with ClinicalTrials.gov, number NCT00224770.Between Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7-22.6] vs eight [14·8%, 6·6-27·1], p=0·542), 7 day mortality (zero [0%, 0-8·4] vs one [1·9%, 0·1-9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1-12·6] vs five [9·3%, 3·1-20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1-12·6] vs zero [0%, 0-6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0-35·6] vs three [7·1%; 1·5-19·5]; p=0·051).FINDINGSBetween Feb 2, 2006, and April 8, 2013, 96 patients were randomly allocated and completed follow-up: 54 (56%) in the MIS plus alteplase group and 42 (44%) in the standard medical care group. The primary outcomes did not differ between the standard medical care and MIS plus alteplase groups: 30 day mortality (four [9·5%, 95% CI 2·7-22.6] vs eight [14·8%, 6·6-27·1], p=0·542), 7 day mortality (zero [0%, 0-8·4] vs one [1·9%, 0·1-9·9], p=0·562), symptomatic bleeding (one [2·4%, 0·1-12·6] vs five [9·3%, 3·1-20·3], p=0·226), and brain bacterial infections (one [2·4%, 0·1-12·6] vs zero [0%, 0-6·6], p=0·438). Asymptomatic haemorrhages were more common in the MIS plus alteplase group than in the standard medical care group (12 [22·2%; 95% CI 12·0-35·6] vs three [7·1%; 1·5-19·5]; p=0·051).MIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage.INTERPRETATIONMIS plus alteplase seems to be safe in patients with intracerebral haemorrhage, but increased asymptomatic bleeding is a major cautionary finding. These results, if replicable, could lead to the addition of surgical management as a therapeutic strategy for intracerebral haemorrhage.National Institute of Neurological Disorders and Stroke, Genentech, and Codman.FUNDINGNational Institute of Neurological Disorders and Stroke, Genentech, and Codman. |
| Author | Mendelow, A David Graham, R Scott Morgan, Tim C Muschelli, John Awad, Issam Zuccarello, Mario Wijman, Cristanne Kase, Carlos Mayo, Steven W Rosenblum, Michael Lane, Karen Vespa, Paul Martin, Neil Aldrich, E Francois Yenokyan, Gayane Broaddus, William C Mould, W Andrew McBee, Nichol Bistran-Hall, Amanda J Camarata, Paul Gregson, Barbara Huang, Judy Thompson, Richard E Huang, Emily Caron, Jean-Louis Keyl, Penelope Carhuapoma, J Ricardo Hanley, Daniel F Gandhi, Dheeraj Dodd, Robert Thompson, Carol B Ziai, Wendy Janis, Scott Ullman, Natalie |
| Author_xml | – sequence: 1 givenname: Daniel F surname: Hanley fullname: Hanley, Daniel F email: dhanley@jhmi.edu organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 2 givenname: Richard E surname: Thompson fullname: Thompson, Richard E organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 3 givenname: John surname: Muschelli fullname: Muschelli, John organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 4 givenname: Michael surname: Rosenblum fullname: Rosenblum, Michael organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 5 givenname: Nichol surname: McBee fullname: McBee, Nichol organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 6 givenname: Karen surname: Lane fullname: Lane, Karen organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 7 givenname: Amanda J surname: Bistran-Hall fullname: Bistran-Hall, Amanda J organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 8 givenname: Steven W surname: Mayo fullname: Mayo, Steven W organization: Emissary International, Austin, TX, USA – sequence: 9 givenname: Penelope surname: Keyl fullname: Keyl, Penelope organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 10 givenname: Dheeraj surname: Gandhi fullname: Gandhi, Dheeraj organization: Department of Neuroradiology, University of Maryland, Baltimore, MD, USA – sequence: 11 givenname: Tim C surname: Morgan fullname: Morgan, Tim C organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 12 givenname: Natalie surname: Ullman fullname: Ullman, Natalie organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 13 givenname: W Andrew surname: Mould fullname: Mould, W Andrew organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 14 givenname: J Ricardo surname: Carhuapoma fullname: Carhuapoma, J Ricardo organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 15 givenname: Carlos surname: Kase fullname: Kase, Carlos organization: Department of Neurology, Boston University, Boston, MA, USA – sequence: 16 givenname: Wendy surname: Ziai fullname: Ziai, Wendy organization: Department of Neurology, Brain Injury Outcomes Coordinating Center, Johns Hopkins University, Baltimore, MD, USA – sequence: 17 givenname: Carol B surname: Thompson fullname: Thompson, Carol B organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 18 givenname: Gayane surname: Yenokyan fullname: Yenokyan, Gayane organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 19 givenname: Emily surname: Huang fullname: Huang, Emily organization: Department of Biostatistics, School of Public Health, Johns Hopkins University, Baltimore, MD, USA – sequence: 20 givenname: William C surname: Broaddus fullname: Broaddus, William C organization: Department of Neurology, Virginia Commonwealth University, Richmond, VA, USA – sequence: 21 givenname: R Scott surname: Graham fullname: Graham, R Scott organization: Department of Neurosurgery, Virginia Commonwealth University, Richmond, VA, USA – sequence: 22 givenname: E Francois surname: Aldrich fullname: Aldrich, E Francois organization: Department of Neurosurgery, University of Maryland, Baltimore, MD, USA – sequence: 23 givenname: Robert surname: Dodd fullname: Dodd, Robert organization: Department of Neurosurgery, Stanford University, Palo Alto, CA, USA – sequence: 24 givenname: Cristanne surname: Wijman fullname: Wijman, Cristanne organization: Department of Neurology, Stanford University, Palo Alto, CA, USA – sequence: 25 givenname: Jean-Louis surname: Caron fullname: Caron, Jean-Louis organization: Department of Neurosurgery, University of Texas, San Antonio, TX, USA – sequence: 26 givenname: Judy surname: Huang fullname: Huang, Judy organization: Department of Neurosurgery, Johns Hopkins University, Baltimore, MD, USA – sequence: 27 givenname: Paul surname: Camarata fullname: Camarata, Paul organization: Department of Neurosurgery, University of Kansas, Kansas City, KS, USA – sequence: 28 givenname: A David surname: Mendelow fullname: Mendelow, A David organization: Neurosurgery, Newcastle University, Newcastle upon Tyne, UK – sequence: 29 givenname: Barbara surname: Gregson fullname: Gregson, Barbara organization: Neurosurgery, Newcastle University, Newcastle upon Tyne, UK – sequence: 30 givenname: Scott surname: Janis fullname: Janis, Scott organization: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA – sequence: 31 givenname: Paul surname: Vespa fullname: Vespa, Paul organization: Department of Neurology, University of California, Los Angeles, Los Angeles, CA, USA – sequence: 32 givenname: Neil surname: Martin fullname: Martin, Neil organization: Department of Neurosurgery, University of California, Los Angeles, Los Angeles, CA, USA – sequence: 33 givenname: Issam surname: Awad fullname: Awad, Issam organization: Department of Neurosurgery, University of Chicago, Chicago, IL, USA – sequence: 34 givenname: Mario surname: Zuccarello fullname: Zuccarello, Mario organization: Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27751554$$D View this record in MEDLINE/PubMed |
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| Snippet | Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive catheter... Summary Background Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally... Background Craniotomy, according to the results from trials, does not improve functional outcome after intracerebral haemorrhage. Whether minimally invasive... |
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| SubjectTerms | Aged Blood pressure Cerebral Hemorrhage - drug therapy Cerebral Hemorrhage - mortality Cerebral Hemorrhage - surgery Coma Combined Modality Therapy Female Fibrinolytic Agents - administration & dosage Fibrinolytic Agents - adverse effects Fibrinolytic Agents - pharmacology Follow-Up Studies Hemorrhage Humans Intensive care Laparoscopy Male Middle Aged Minimally Invasive Surgical Procedures Mortality Neurology Outcome Assessment (Health Care) Patients Postoperative Hemorrhage - etiology Pragmatism Stroke Surgery Surgery, Computer-Assisted Thrombectomy - adverse effects Thrombectomy - methods Tissue Plasminogen Activator - administration & dosage Tissue Plasminogen Activator - adverse effects Tissue Plasminogen Activator - pharmacology |
| Title | Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial |
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