Intracranial Hematoma, Ischemic Stroke
Conditions
Brief summary
The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.
Interventions
DEVICEMechanical thrombectomy
1. Clot specimen collection 2. Extracranial blood collection
OTHERMinimally invasive surgery
1. Clot specimen collection 2. Arterial blood collection
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 Years of Age * Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS) * Extracted thrombus/embolus * Informed consent is obtained from either the patient or legally authorized representative (LAR)
Exclusion criteria
* Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable) * Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood and Clot Specimen Proteomics | Blood and clot specimen obtained during procedure | Numbers of blood and clot specimen for proteomic analysis |
| Clot Specimen Histology | Clot specimen obtained during procedure | Numbers of clot specimen for histology analysis |
| Blood and Clot Specimen Transcriptomics | Blood and clot specimen obtained during procedure | Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed. |
| Blood and Clot Specimen Genomics | Blood and clot specimen obtained during procedure | Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Ischemic Stroke Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection | 388 |
| Patients With Intracranial Hematoma Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection | 12 |
| Total | 400 |
Baseline characteristics
| Characteristic | Patients With Intracranial Hematoma | Total | Patients With Ischemic Stroke |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 11.65 | 68.9 years STANDARD_DEVIATION 14.8 | 69.1 years STANDARD_DEVIATION 14.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 13 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 367 Participants | 360 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 20 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 75 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 36 Participants | 31 Participants |
| Race (NIH/OMB) White | 3 Participants | 279 Participants | 276 Participants |
| Sex: Female, Male Female | 3 Participants | 206 Participants | 203 Participants |
| Sex: Female, Male Male | 9 Participants | 194 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 86 / 388 | 3 / 12 |
| other Total, other adverse events | 11 / 165 | 0 / 0 |
| serious Total, serious adverse events | 38 / 165 | 0 / 0 |
Outcome results
Primary
Blood and Clot Specimen Genomics
Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed.
Time frame: Blood and clot specimen obtained during procedure
Population: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Ischemic Stroke | Blood and Clot Specimen Genomics | 387 Count of specimen |
| Patients With Intracranial Hematoma | Blood and Clot Specimen Genomics | 12 Count of specimen |
Primary
Blood and Clot Specimen Proteomics
Numbers of blood and clot specimen for proteomic analysis
Time frame: Blood and clot specimen obtained during procedure
Population: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Ischemic Stroke | Blood and Clot Specimen Proteomics | Clot Protein Analysis | 351 Count of specimen |
| Patients With Ischemic Stroke | Blood and Clot Specimen Proteomics | Blood Protein Analysis | 366 Count of specimen |
| Patients With Intracranial Hematoma | Blood and Clot Specimen Proteomics | Clot Protein Analysis | 12 Count of specimen |
| Patients With Intracranial Hematoma | Blood and Clot Specimen Proteomics | Blood Protein Analysis | 12 Count of specimen |
Primary
Blood and Clot Specimen Transcriptomics
Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.
Time frame: Blood and clot specimen obtained during procedure
Population: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Ischemic Stroke | Blood and Clot Specimen Transcriptomics | Clot RNA Analyzed | 341 Count of specimen |
| Patients With Ischemic Stroke | Blood and Clot Specimen Transcriptomics | Blood RNA Analyzed | 365 Count of specimen |
| Patients With Intracranial Hematoma | Blood and Clot Specimen Transcriptomics | Clot RNA Analyzed | 9 Count of specimen |
| Patients With Intracranial Hematoma | Blood and Clot Specimen Transcriptomics | Blood RNA Analyzed | 12 Count of specimen |
Primary
Clot Specimen Histology
Numbers of clot specimen for histology analysis
Time frame: Clot specimen obtained during procedure
Population: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Ischemic Stroke | Clot Specimen Histology | 373 Count of specimen |
| Patients With Intracranial Hematoma | Clot Specimen Histology | 12 Count of specimen |