Trial · NCT03000283
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
NCT03000283, Phase 1, Completed, Jesse Corry; results first posted 2020-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study. Trials, record NCT03000283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03000283
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
- NCT number
- NCT03000283
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Jesse Corry
- Conditions
- Cerebral Hemorrhage, Cerebral Edema, Intracerebral Hemorrhage, Stroke
- Interventions
- Conivaptan
- First posted
- 2016-12-22
- Last updated
- 2020-04-17
- Results first posted
- 2020-04-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Tolerance of Conivaptan | Baseline to 168 hours post-enrollment | The number of participants with abnormal seizure activity and/or abnormal lab values and/or increase in infection rate and/or any drug-related adverse events. |
| Secondary | In-hospital Mortality | Enrollment through hospital discharge, up to 3 weeks | All-cause deaths during hospitalization |
| Secondary | Change in Cerebral Edema | Baseline to 168 hours post-enrollment | Changes in cerebral edema (CE) as measured on CT. Goal is a -5 to -10% change in CE over time. Change will be measured both as absolute change in volume, calculated as the final volume minus the baseline volume measure and converted to a percentage of the baseline volume measure. |
| Secondary | Cost | Enrollment through hospital discharge, up to 3 weeks | Cost as measured by length of stay in the neuro ICU. |
| Secondary | Cost | Baseline to 168 hours post-enrollment | Cost as measured by: 1. Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE. 2. Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs). 3. Number of patients requiring a ventilator. |
| Secondary | Modified Rankin Scale (mRS) Score | At discharge from ICU and from hospital, up to 3 weeks | Modified Rankin Scale (0 to 6) at discharge from the hospital. A score of 0 indicates no disability and a score of 6 indicates the patient died. Functional independence is defined as a score of 2 or less. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Tolerance of Conivaptan | Baseline to 168 hours post-enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | In-hospital Mortality | Enrollment through hospital discharge, up to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Cerebral Edema | Baseline to 168 hours post-enrollment | percentage of change from baseline | MEAN | |
| SECONDARY | Cost | Enrollment through hospital discharge, up to 3 weeks | days | MEAN | |
| SECONDARY | Cost | Baseline to 168 hours post-enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Modified Rankin Scale (mRS) Score | At discharge from ICU and from hospital, up to 3 weeks | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Tolerance of Conivaptan | Conivaptan Treatment Group | Abnormal Seizure Activity | 0 | Participants | |
| Patient Tolerance of Conivaptan | Conivaptan Treatment Group | Abnormal Lab Values | 0 | Participants | |
| Patient Tolerance of Conivaptan | Conivaptan Treatment Group | Infections | 1 | Participants | |
| Patient Tolerance of Conivaptan | Conivaptan Treatment Group | Drug-related Adverse Events | 0 | Participants | |
| In-hospital Mortality | Conivaptan Treatment Group | 0 | Participants | ||
| Change in Cerebral Edema | Conivaptan Treatment Group | -37.1 | Full Range -96.2 to 70.7 | percentage of change from baseline | |
| Cost | Conivaptan Treatment Group | 14.4 | Full Range 9.7 to 28.9 | days | |
| Cost | Conivaptan Treatment Group | EVD/bolt or surgical procedures | 0 | Participants | |
| Cost | Conivaptan Treatment Group | Lines or tracheostomy/PEG | 7 | Participants | |
| Cost | Conivaptan Treatment Group | Ventilator | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Conivaptan Treatment Group | 7 | |
| Overall Study | COMPLETED | Conivaptan Treatment Group | 7 | |
| Overall Study | NOT COMPLETED | Conivaptan Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events8
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 |
|---|---|---|---|---|---|---|
| serious | Intracranial Hemorrhage Expansion | Nervous system disorders | Conivaptan Treatment Group | 1 | 7 | |
| serious | Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Conivaptan Treatment Group | 2 | 7 | |
| serious | Urinary Tract Infection | Infections and infestations | Conivaptan Treatment Group | 1 | 7 | |
| serious | Catheterization, Central Venous (PICC) | Surgical and medical procedures | Conivaptan Treatment Group | 7 | 7 | |
| serious | Tracheostomy | Surgical and medical procedures | Conivaptan Treatment Group | 3 | 7 | |
| serious | Gastostomy (PEG) | Surgical and medical procedures | Conivaptan Treatment Group | 2 | 7 | |
| serious | Increase in Cerebral Edema | Nervous system disorders | Conivaptan Treatment Group | 1 | 7 | |
| serious | Deep Vein Thrombosis | Vascular disorders | Conivaptan Treatment Group | 2 | 7 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conivaptan Treatment Group | 0 | 7 |
| Total, other adverse events | Conivaptan Treatment Group | 0 | 7 |
| Total, serious adverse events | Conivaptan Treatment Group | 7 | 7 |
Source ClinicalTrials.gov
Papers44
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 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/NCT03000283
GET https://conductscience.org/api/trials/v1/NCT03000283/papers?page=2