Trial · NCT00964548
Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage
NCT00964548, Phase 1, Phase 2, Completed, University of Massachusetts, Worcester; results first posted 2012-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage. Trials, record NCT00964548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00964548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage
- NCT number
- NCT00964548
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Massachusetts, Worcester
- Conditions
- Cerebral Vasospasm After Subarachnoid Hemorrhage
- Interventions
- Dantrolene, Dantrolene
- First posted
- 2009-08-25
- Last updated
- 2012-05-25
- Results first posted
- 2012-05-25
- Limitations and caveats
Limitations of this trial include the small n. No power analysis was performed, but rather a convenience sample was chosen as this was a proof-of-concept study. Transcranial Doppler measurements are operator dependent.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion). |
| Secondary | Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion). |
| Secondary | Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | mmHg | MEAN | |
| SECONDARY | Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | cm/s | MEAN | |
| SECONDARY | Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | baseline until 135 minutes post-infusion | cm/s | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (Low Dose) | -8 | 95% Confidence Interval -26 to 10 | mmHg | |
| Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (High Dose) | -3.4 | 95% Confidence Interval -19 to 12 | mmHg | |
| Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (Low Dose) | -30 | 95% Confidence Interval -47 to 12 | cm/s | |
| Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (High Dose) | -26 | 95% Confidence Interval -56 to 8 | cm/s | |
| Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (Low Dose) | -18 | 95% Confidence Interval -32 to -3 | cm/s | |
| Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion) | Dantrolene (High Dose) | -13 | 95% Confidence Interval -34 to 8 | cm/s |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dantrolene (Low Dose) | 5 | |
| Overall Study | STARTED | Dantrolene (High Dose) | 5 | |
| Overall Study | COMPLETED | Dantrolene (Low Dose) | 5 | |
| Overall Study | COMPLETED | Dantrolene (High Dose) | 5 | |
| Overall Study | NOT COMPLETED | Dantrolene (Low Dose) | 0 | |
| Overall Study | NOT COMPLETED | Dantrolene (High Dose) | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Venous Irritation | Vascular disorders | Dantrolene (Low Dose) | 0 | 5 | 0 |
| other | Venous Irritation | Vascular disorders | Dantrolene (High Dose) | 0 | 5 | 0 |
| serious | Hypotension | Vascular disorders | Dantrolene (Low Dose) | 1 | 5 | 1 |
| serious | Hypotension | Vascular disorders | Dantrolene (High Dose) | 0 | 5 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dantrolene (Low Dose) | ||
| Total, all-cause mortality | Dantrolene (High Dose) | ||
| Total, other adverse events | Dantrolene (Low Dose) | 0 | 5 |
| Total, other adverse events | Dantrolene (High Dose) | 0 | 5 |
| Total, serious adverse events | Dantrolene (Low Dose) | 1 | 5 |
| Total, serious adverse events | Dantrolene (High Dose) | 0 | 5 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dantrolene (Low Dose) vs Dantrolene (High Dose): serious adverse events |
Source Trial comparisons
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/NCT00964548
GET https://conductscience.org/api/trials/v1/NCT00964548/registered