drugset / Trial / NCT01827046
Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
Phase 3
Completed
499 enrolled
Johns Hopkins University
Emissary International LLC · collabGenentech, Inc. · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
Timeline
- Start
- 2013-12-30
- Primary completion
- 2018-09
- Completion
- 2018-09
Outcome
Missed primary endpoint
paper The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). PMID 30739747 ↗
paper INTERPRETATION: For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. PMID 30739747 ↗
Publications
- Murray ON, Jenkins DA, Walborn N, Patel HC, Harston G, Cootes T, Klijn CJ, Ziai W, Hanley DF, Hammerbeck U, Parry-Jones AR. Corticospinal tract risk modifies motor recovery after minimally invasive surgery for intracerebral hemorrhage: a secondary analysis of MISTIE-III. medRxiv [Preprint]. 2026 Jun 11:2026.06.10.26354920. doi: 10.64898/2026.06.10.26354920.
- Cooper DC, Abramson E, Ziai WC, Flaherty ML, Shah VA, Avadhani R, Ostapkovich N, Carhuapoma L, Awad I, Zuccarello M, Hanley D, Sansing LH. Intracerebral haemorrhage laterality and associations with mood and pain: a MISTIE III substudy. Stroke Vasc Neurol. 2025 Dec 23;10(6):734-742. doi: 10.1136/svn-2024-003755.
- Sun P, Badihian S, Avadhani R, Walborn N, Yarava A, Alimoradi D, Awad I, Hanley D, Murthy S, Ziai W. Does stereotactic thrombolysis with alteplase for intracerebral haemorrhage alter intraventricular haematoma volume? A secondary analysis of the MISTIE-III trial. J Neurol Neurosurg Psychiatry. 2024 Sep 17;95(10):892-898. doi: 10.1136/jnnp-2023-333032.
- Rivera-Lara L, Cho SM, Li Y, Ali H, McBee N, Awad IA, Avadhani R, Hanley DF, Gandhi D, Walborn N, Murthy SB, Ziai WC. Mechanistic Evaluation of Diffusion Weighted Hyperintense Lesions After Large Spontaneous Intracerebral Hemorrhage: A Subgroup Analysis of MISTIE III. Neurocrit Care. 2024 Jun;40(3):1140-1150. doi: 10.1007/s12028-023-01890-3. Epub 2023 Dec 1.
- Bako AT, Potter T, Pan AP, Tannous J, Britz G, Ziai WC, Awad I, Hanley D, Vahidy FS. Minimally Invasive Surgery With Thrombolysis for Intracerebral Hemorrhage Evacuation: Bayesian Reanalysis of a Randomized Controlled Trial. Neurology. 2023 Oct 17;101(16):e1614-e1622. doi: 10.1212/WNL.0000000000207735. Epub 2023 Sep 8.
- Magid-Bernstein JR, Li Y, Cho SM, Piran PJ, Roh DJ, Gupta A, Shoamanesh A, Merkler A, Zhang C, Avadhani R, Montano N, Iadecola C, Falcone GJ, Sheth KN, Qureshi AI, Rosand J, Goldstein J, Awad I, Hanley DF, Kamel H, Ziai WC, Murthy SB. Cerebral Microbleeds and Acute Hematoma Characteristics in the ATACH-2 and MISTIE III Trials. Neurology. 2022 Mar 8;98(10):e1013-e1020. doi: 10.1212/WNL.0000000000013247. Epub 2021 Dec 22.
- Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 1 mg | Other |