Trial · NCT01024972

Safety Study of Dantrolene in Subarachnoid Hemorrhage

NCT01024972, Phase 1, Phase 2, Completed, University of Massachusetts, Worcester; results first posted 2015-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Dantrolene in Subarachnoid Hemorrhage. Trials, record NCT01024972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01024972

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study of Dantrolene in Subarachnoid Hemorrhage
NCT number: NCT01024972
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 31 participants, actual
Lead sponsor: University of Massachusetts, Worcester
Conditions: Subarachnoid Hemorrhage, Cerebral Vasospasm
Interventions: Dantrolene, Placebo
First posted: 2009-12-03
Last updated: 2015-03-05
Results first posted: 2015-03-05
Limitations and caveats: Placebo group consisted of free water with 5% mannitol to achieve the same equiosmolar solution as IV-D which requires reconstitution in free water. Unable to differentiate whether hyponatremia or brain oedema was due to IV-D or its solution.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hyponatremia	Seven days	Number of subjects who developed hyponatremia (sNa ≤132mmol/L)
Secondary	Liver Toxicity	7 days	Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal.
Secondary	In-hospital Mortality	up to 90 days	Number of subjects who expired during hospitalization.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Hyponatremia	Seven days	participants	NUMBER
SECONDARY	Liver Toxicity	7 days	participants	NUMBER
SECONDARY	In-hospital Mortality	up to 90 days	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Hyponatremia	Dantrolene	7	participants
Hyponatremia	Placebo	10	participants
Liver Toxicity	Dantrolene	1	participants
Liver Toxicity	Placebo	0	participants
In-hospital Mortality	Dantrolene	2	participants
In-hospital Mortality	Placebo	1	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dantrolene	16
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Dantrolene	16
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Dantrolene	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events22

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 infiltration	Vascular disorders	Dantrolene	4	16	4
other	Venous infiltration	Vascular disorders	Placebo	0	15	0
other	Nausea/vomiting	Gastrointestinal disorders	Dantrolene	3	16	3
other	Nausea/vomiting	Gastrointestinal disorders	Placebo	1	15	1
other	Headache	Nervous system disorders	Dantrolene	2	16	2
other	Headache	Nervous system disorders	Placebo	0	15	0
other	Urinary tract infection	Renal and urinary disorders	Dantrolene	1	16	1
other	Urinary tract infection	Renal and urinary disorders	Placebo	0	15	0
other	Myocardial Infarction	Cardiac disorders	Dantrolene	1	16	1
other	Myocardial Infarction	Cardiac disorders	Placebo	0	15	0

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dantrolene
Total, all-cause mortality	Placebo
Total, other adverse events	Dantrolene	12	16
Total, other adverse events	Placebo	1	15
Total, serious adverse events	Dantrolene	4	16
Total, serious adverse events	Placebo	2	15

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18696266	BACKGROUND	PubMed
18696267	BACKGROUND	PubMed
18923817	BACKGROUND	PubMed
21454813	BACKGROUND	PubMed
25344064	RESULT	PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dantrolene vs Placebo: Liver Toxicity	Trial comparisons
Dantrolene vs Placebo: Hyponatremia	Trial comparisons
Dantrolene vs Placebo: In-hospital Mortality	Trial comparisons
Dantrolene vs Placebo: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01024972

GET https://conductscience.org/api/trials/v1/NCT01024972/events?page=2

API reference For AI assistants