Trial · NCT01014975
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
NCT01014975, Phase 1, Phase 2, Completed, Grifols Therapeutics LLC; results first posted 2015-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients. Trials, record NCT01014975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01014975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
- NCT number
- NCT01014975
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Grifols Therapeutics LLC
- Conditions
- Acute Ischemic Stroke
- Interventions
- Plasmin (Human), Plasmin (Human), Plasmin (Human)
- First posted
- 2009-11-17
- Last updated
- 2015-10-21
- Other registries' IDs
- eudract:2010-019760-36
- Results first posted
- 2015-10-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort | 90 days |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort | 90 days | Safety Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort | 20 mg Plasmin (Human) | 0 | participants | ||
| Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort | 40 mg Plasmin (Human) | 0 | participants | ||
| Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort | 80 mg Plasmin (Human) | 0 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20 mg Plasmin (Human) | 8 | |
| Overall Study | STARTED | 40 mg Plasmin (Human) | 16 | |
| Overall Study | STARTED | 80 mg Plasmin (Human) | 16 | |
| Overall Study | COMPLETED | 20 mg Plasmin (Human) | 4 | |
| Overall Study | COMPLETED | 40 mg Plasmin (Human) | 13 | |
| Overall Study | COMPLETED | 80 mg Plasmin (Human) | 10 | |
| Overall Study | NOT COMPLETED | 20 mg Plasmin (Human) | 4 | |
| Overall Study | NOT COMPLETED | 40 mg Plasmin (Human) | 3 | |
| Overall Study | NOT COMPLETED | 80 mg Plasmin (Human) | 6 |
Source ClinicalTrials.gov
Adverse events336
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HEADACHE | Nervous system disorders | 20 mg Plasmin (Human) | 2 | 8 | |
| other | HEADACHE | Nervous system disorders | 40 mg Plasmin (Human) | 2 | 16 | |
| other | HEADACHE | Nervous system disorders | 80 mg Plasmin (Human) | 0 | 16 | |
| other | CEREBRAL HAEMORRHAGE | Nervous system disorders | 20 mg Plasmin (Human) | 1 | 8 | |
| other | CEREBRAL HAEMORRHAGE | Nervous system disorders | 40 mg Plasmin (Human) | 1 | 16 | |
| other | CEREBRAL HAEMORRHAGE | Nervous system disorders | 80 mg Plasmin (Human) | 0 | 16 | |
| other | MUSCLE SPASTICITY | Nervous system disorders | 20 mg Plasmin (Human) | 1 | 8 | |
| other | MUSCLE SPASTICITY | Nervous system disorders | 40 mg Plasmin (Human) | 0 | 16 | |
| other | MUSCLE SPASTICITY | Nervous system disorders | 80 mg Plasmin (Human) | 1 | 16 | |
| other | CENTRAL PAIN SYNDROME | Nervous system disorders | 20 mg Plasmin (Human) | 0 | 8 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20 mg Plasmin (Human) | ||
| Total, all-cause mortality | 40 mg Plasmin (Human) | ||
| Total, all-cause mortality | 80 mg Plasmin (Human) | ||
| Total, other adverse events | 20 mg Plasmin (Human) | 8 | 8 |
| Total, other adverse events | 40 mg Plasmin (Human) | 12 | 16 |
| Total, other adverse events | 80 mg Plasmin (Human) | 12 | 16 |
| Total, serious adverse events | 20 mg Plasmin (Human) | 6 | 8 |
| Total, serious adverse events | 40 mg Plasmin (Human) | 7 | 16 |
| Total, serious adverse events | 80 mg Plasmin (Human) | 7 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01014975
GET https://conductscience.org/api/trials/v1/NCT01014975/events?page=2