Cerebral HemorrhagePhase 1NCT03000283
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
A Phase 1 study testing Conivaptan in people with Cerebral Hemorrhage and Cerebral Edema, run by Jesse Corry at 1 site in United States.
Trial summary
The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Cerebral Hemorrhage, Cerebral Edema, Intracerebral Hemorrhage
- What is being tested?
- Conivaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 15 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old and < 80 years.
- Diagnosis of primary ICH > 20 cc in volume.
- Enrollment within 48 hours from initial symptoms.
- Signed informed consent from the patient or obtained via their legally authorized representative (if the patient is not able to sign the informed consent themselves). The patient's decisional capacity to either provide or refuse consent will be determined using the Glasgow Coma Scale (GCS), which is being assessed at baseline and at 24 hours (+/-6hrs) after enrollment. A potential study participant with a GCS > 14 will be asked to provide their own initial study consent. A GCS ≤ 14 would indicate the need to pursue consent via legally authorized representative.
Who cannot join
- Current need for renal replacement therapy (RRT).
- Glomerular filtration rate (GFR) of <30 mL/minute at time of admission.
- Participation in another study for ICH or intraventricular hemorrhage.
- ICH related to infection, thrombolysis, subarachnoid hemorrhage, trauma or tumor.
- Presence of HIV or active fungal infection that is known based on information in the electronic medical record (EMR).
- Continued use of digoxin or amlodipine (as recommended by the manufacturer due to cytochrome P450 3A4 "CYP3A" inhibition).
Show all 11Show fewer
- Active hepatic failure as defined by aspartate aminotransferase (AST) >160 units/L and/or alanine transaminase (ALT) >180 units/L, or total bilirubin levels greater than four times normal levels (>4.8mg/dL).
- Serum Na+> 145 mmol/L (admission labs or any time prior to recruitment/enrollment).
- Unable to receive conivaptan based on contraindications indicated by the manufacturer.
- Pregnant or lactating females.
- Not expected to survive within 48 hours of admission, or a presumed diagnosis of brain death.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management.
Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.
Read the detailed description
This is a single-center, open-label, safety and tolerability study. Based on findings in the literature from both animal research and clinical observations with ICH (intracerebral hemorrhage) associated with TBI (traumatic brain injury), this study will begin to look at the safety, tolerability, as well as potential effectiveness, of conivaptan to reduce CE (cerebral edema) in patients with non-traumatic ICH.
The seven patients in this study will receive 40mg/day of the study medication conivaptan. In this early phase study, our focus will be to assess the safety and tolerability of this medication. The available clinical data on conivaptan in the neurocritical care population suggest the potential harm is negligible. Data in TBI patients demonstrate conivaptan is safe and well tolerated using a single dose (20mg) to increase Na+ in a controlled fashion to reduce ICP. Previous work has demonstrated the safety and tolerability of conivaptan, in doses ranging from 20-80mg/day, in the neurocritical care population. Conivaptan has been demonstrated to be safe and effective in lowering ICP, and increasing serum sodium, in the neurocritical care population. Also noted have been improvements in cerebral perfusion pressure (CPP) and stable blood pressure, and a prolonged reduction in ICP. Finally, the method of intermittent bolus dosing of conivaptan is equally effective in raising and maintaining serum sodium in the neurocritical care population as continuous infusion, with potentially less risk of adverse reactions including phlebitis.
Conivaptan, a non-selective Arginine-Vasopressin (AVP) V1A/V2 antagonist that reduces aquaporin 4 production and promotes aquaresis, is approved for the treatment of euvolemic and hypervolemic hyponatremia. The exact cause of the observed reduction in ICP with conivaptan is uncertain. However, the mechanism most likely represents a combination of an acute pure aquaresis, removing free water from brain tissue, and a sustained down regulation of aquaporin 4 to abate/slow development of CE. The V2 antagonism of conivaptan promotes free water loss, and the V1 antagonism may improve cerebral blood flow (CBF) and reduce blood brain barrier permeability. Notably, serum sodium tends to correlate inversely with both ICP and CE. The early use of conivaptan could potentially be used clinically to reduce CE by these means.
It is with this in mind, the research team feels justified in pursuing this study with the hopes that the data obtained will lead to potential good and removal of harm in future patients with this devastating disease. Given the enormous costs of ICH, problems with current therapies, and variability in treatment, there is an urgent need to identify a therapy that has a better safety and effectiveness profile compared to the currently used agents. This study will use a dose (40mg/day) currently approved. Further, given that the primary purpose of the use of this medication in this study is not to correct hyponatremia, an investigational new drug (IND) application to the FDA was submitted, and the study was determined exempt.
Our central hypothesis is that through reductions in aquaporin-4 (AQP4) expression, the early use of conivaptan will reduce CE while also being safe to the patient. Our long term goal is to show that early use of conivaptan in ICH will reduce CE. If this reduction is possible, we hypothesize improved outcome and reducing the need for rescue therapies, ICU length of stay, and overall treatment cost will follow. However, more data is needed to evaluate the dosing and amount of drug. With respect to conivaptan's efficacy in correction of hyponatremia, a direct dose-response relationship exists. Further, this effect was more noted at milder degrees of hyponatremia.
- Conditions
- Cerebral Hemorrhage, Cerebral Edema, Intracerebral Hemorrhage, Stroke
- Being tested
- Conivaptan
- Keywords
- Conivaptan
- Medical subject headings
- Cerebral Hemorrhage, Brain Edema, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConivaptanDrug
Also called Vaprisol
Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.
The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line.
| Study group | Role | What they receive |
|---|---|---|
| Conivaptan Treatment Group | Experimental | All seven patients in this arm will receive conivaptan as described in Interventions. Receives: Drug: Conivaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Tolerance of Conivaptan
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.
Measured: Baseline to 168 hours post-enrollment
Secondary outcomes (5)
In-hospital Mortality
All-cause deaths during hospitalization
Measured: Enrollment through hospital discharge, up to 3 weeks
Change in Cerebral Edema
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.
Measured: Baseline to 168 hours post-enrollment
Cost
Cost as measured by length of stay in the neuro ICU.
Measured: Enrollment through hospital discharge, up to 3 weeks
Cost
Cost as measured by:
- Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE.
- Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs).
- Number of patients requiring a ventilator.
Measured: Baseline to 168 hours post-enrollment
Modified Rankin Scale (mRS) Score
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.
Measured: At discharge from ICU and from hospital, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start22 Mar 2017
- Primary completion12 Feb 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesse Corry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jesse Corry, Allina Health System
- Investigators
- Jesse J Corry, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000283
- Sponsor's protocol ID
- NSJC-1601
- Status last verified
- Apr 2020
- First submitted
- 14 Dec 2016
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annane D, Decaux G, Smith N; Conivaptan Study Group. Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia. Am J Med Sci. 2009 Jan;337(1):28-36. doi: 10.1097/MAJ.0b013e31817b8148.
PubMed 19057376Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405.
PubMed 20924011Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12.
PubMed 23234472Corry JJ, Varelas P, Abdelhak T, Morris S, Hawley M, Hawkins A, Jankowski M. Variable change in renal function by hypertonic saline. World J Crit Care Med. 2014 May 4;3(2):61-7. doi: 10.5492/wjccm.v3.i2.61. eCollection 2014 May 4.
PubMed 24892021Corry JJ. The use of targeted temperature management for elevated intracranial pressure. Curr Neurol Neurosci Rep. 2014 Jun;14(6):453. doi: 10.1007/s11910-014-0453-9.
PubMed 24740807Corry JJ. Use of hypothermia in the intensive care unit. World J Crit Care Med. 2012 Aug 4;1(4):106-22. doi: 10.5492/wjccm.v1.i4.106. eCollection 2012 Aug 4.
PubMed 24701408Costello-Boerrigter LC, Boerrigter G, Burnett JC Jr. Pharmacology of vasopressin antagonists. Heart Fail Rev. 2009 Jun;14(2):75-82. doi: 10.1007/s10741-008-9108-8. Epub 2008 Sep 3.
PubMed 18766438Adams Jr HP. Handbook of Cerebrovascular Disease. Ed.2 Marcel Dekker, Inc, New York, 2005
Cumberland Pharmaceuticals, Inc. Vaprisol ® (conivaptan hydrochloride injection) [package insert]. Nashville, TN, April 2014.
Dhar R, Murphy-Human T. A bolus of conivaptan lowers intracranial pressure in a patient with hyponatremia after traumatic brain injury. Neurocrit Care. 2011 Feb;14(1):97-102. doi: 10.1007/s12028-010-9366-x.
PubMed 20440600Diringer MN, Edwards DF. Admission to a neurologic/neurosurgical intensive care unit is associated with reduced mortality rate after intracerebral hemorrhage. Crit Care Med. 2001 Mar;29(3):635-40. doi: 10.1097/00003246-200103000-00031.
PubMed 11373434FDA. http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm (2010)
Fernandez N, Martinez MA, Garcia-Villalon AL, Monge L, Dieguez G. Cerebral vasoconstriction produced by vasopressin in conscious goats: role of vasopressin V(1) and V(2) receptors and nitric oxide. Br J Pharmacol. 2001 Apr;132(8):1837-44. doi: 10.1038/sj.bjp.0704034.
PubMed 11309256Galton C, Deem S, Yanez ND, Souter M, Chesnut R, Dagal A, Treggiari M. Open-label randomized trial of the safety and efficacy of a single dose conivaptan to raise serum sodium in patients with traumatic brain injury. Neurocrit Care. 2011 Jun;14(3):354-60. doi: 10.1007/s12028-011-9525-8.
PubMed 21409494Gazitua S, Scott JB, Chou CC, Haddy FJ. Effect of osmolarity on canine renal vascular resistance. Am J Physiol. 1969 Oct;217(4):1216-23. doi: 10.1152/ajplegacy.1969.217.4.1216. No abstract available.
PubMed 5824323
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
- ClinicalTrials.gov ID
- NCT03000283
- Acronym / sponsor ID
- NSJC-1601
- Conditions
- Cerebral Hemorrhage, Cerebral Edema, Intracerebral Hemorrhage, Stroke
- Keywords
- Conivaptan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jesse CorryUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management.
Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.
Detailed description
This is a single-center, open-label, safety and tolerability study. Based on findings in the literature from both animal research and clinical observations with ICH (intracerebral hemorrhage) associated with TBI (traumatic brain injury), this study will begin to look at the safety, tolerability, as well as potential effectiveness, of conivaptan to reduce CE (cerebral edema) in patients with non-traumatic ICH.
The seven patients in this study will receive 40mg/day of the study medication conivaptan. In this early phase study, our focus will be to assess the safety and tolerability of this medication. The available clinical data on conivaptan in the neurocritical care population suggest the potential harm is negligible. Data in TBI patients demonstrate conivaptan is safe and well tolerated using a single dose (20mg) to increase Na+ in a controlled fashion to reduce ICP. Previous work has demonstrated the safety and tolerability of conivaptan, in doses ranging from 20-80mg/day, in the neurocritical care population. Conivaptan has been demonstrated to be safe and effective in lowering ICP, and increasing serum sodium, in the neurocritical care population. Also noted have been improvements in cerebral perfusion pressure (CPP) and stable blood pressure, and a prolonged reduction in ICP. Finally, the method of intermittent bolus dosing of conivaptan is equally effective in raising and maintaining serum sodium in the neurocritical care population as continuous infusion, with potentially less risk of adverse reactions including phlebitis.
Conivaptan, a non-selective Arginine-Vasopressin (AVP) V1A/V2 antagonist that reduces aquaporin 4 production and promotes aquaresis, is approved for the treatment of euvolemic and hypervolemic hyponatremia. The exact cause of the observed reduction in ICP with conivaptan is uncertain. However, the mechanism most likely represents a combination of an acute pure aquaresis, removing free water from brain tissue, and a sustained down regulation of aquaporin 4 to abate/slow development of CE. The V2 antagonism of conivaptan promotes free water loss, and the V1 antagonism may improve cerebral blood flow (CBF) and reduce blood brain barrier permeability. Notably, serum sodium tends to correlate inversely with both ICP and CE. The early use of conivaptan could potentially be used clinically to reduce CE by these means.
It is with this in mind, the research team feels justified in pursuing this study with the hopes that the data obtained will lead to potential good and removal of harm in future patients with this devastating disease. Given the enormous costs of ICH, problems with current therapies, and variability in treatment, there is an urgent need to identify a therapy that has a better safety and effectiveness profile compared to the currently used agents. This study will use a dose (40mg/day) currently approved. Further, given that the primary purpose of the use of this medication in this study is not to correct hyponatremia, an investigational new drug (IND) application to the FDA was submitted, and the study was determined exempt.
Our central hypothesis is that through reductions in aquaporin-4 (AQP4) expression, the early use of conivaptan will reduce CE while also being safe to the patient. Our long term goal is to show that early use of conivaptan in ICH will reduce CE. If this reduction is possible, we hypothesize improved outcome and reducing the need for rescue therapies, ICU length of stay, and overall treatment cost will follow. However, more data is needed to evaluate the dosing and amount of drug. With respect to conivaptan's efficacy in correction of hyponatremia, a direct dose-response relationship exists. Further, this effect was more noted at milder degrees of hyponatremia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conivaptan Treatment Group | Experimental | Drug: ConivaptanAll seven patients in this arm will receive conivaptan as described in Interventions. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years old and < 80 years.
- Diagnosis of primary ICH > 20 cc in volume.
- Enrollment within 48 hours from initial symptoms.
- Signed informed consent from the patient or obtained via their legally authorized representative (if the patient is not able to sign the informed consent themselves). The patient's decisional capacity to either provide or refuse consent will be determined using the Glasgow Coma Scale (GCS), which is being assessed at baseline and at 24 hours (+/-6hrs) after enrollment. A potential study participant with a GCS > 14 will be asked to provide their own initial study consent. A GCS ≤ 14 would indicate the need to pursue consent via legally authorized representative.
Key exclusion criteria (11 listed)
- Current need for renal replacement therapy (RRT).
- Glomerular filtration rate (GFR) of <30 mL/minute at time of admission.
- Participation in another study for ICH or intraventricular hemorrhage.
- ICH related to infection, thrombolysis, subarachnoid hemorrhage, trauma or tumor.
- Presence of HIV or active fungal infection that is known based on information in the electronic medical record (EMR).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConivaptanAlso: VaprisolPatients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. | Drug | Conivaptan Treatment Group |
Primary outcome
Patient Tolerance of Conivaptan
Time frame: 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.
5 secondary outcomes
In-hospital Mortality
Time frame: Enrollment through hospital discharge, up to 3 weeks
Change in Cerebral Edema
Time frame: Baseline to 168 hours post-enrollment
Cost
Time frame: Enrollment through hospital discharge, up to 3 weeks
Cost
Time frame: Baseline to 168 hours post-enrollment
Modified Rankin Scale (mRS) Score
Time frame: At discharge from ICU and from hospital, up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19057376Annane D, Decaux G, Smith N; Conivaptan Study Group. Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia. Am J Med Sci. 2009 Jan;337(1):28-36. doi: 10.1097/MAJ.0b013e31817b8148.
- Background: PubMed 20924011Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405.
- Background: PubMed 23234472Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12.
- Background: PubMed 24892021Corry JJ, Varelas P, Abdelhak T, Morris S, Hawley M, Hawkins A, Jankowski M. Variable change in renal function by hypertonic saline. World J Crit Care Med. 2014 May 4;3(2):61-7. doi: 10.5492/wjccm.v3.i2.61. eCollection 2014 May 4.
- Background: PubMed 24740807Corry JJ. The use of targeted temperature management for elevated intracranial pressure. Curr Neurol Neurosci Rep. 2014 Jun;14(6):453. doi: 10.1007/s11910-014-0453-9.
- Background: PubMed 24701408Corry JJ. Use of hypothermia in the intensive care unit. World J Crit Care Med. 2012 Aug 4;1(4):106-22. doi: 10.5492/wjccm.v1.i4.106. eCollection 2012 Aug 4.
- Background: PubMed 18766438Costello-Boerrigter LC, Boerrigter G, Burnett JC Jr. Pharmacology of vasopressin antagonists. Heart Fail Rev. 2009 Jun;14(2):75-82. doi: 10.1007/s10741-008-9108-8. Epub 2008 Sep 3.
- BackgroundAdams Jr HP. Handbook of Cerebrovascular Disease. Ed.2 Marcel Dekker, Inc, New York, 2005
- BackgroundCumberland Pharmaceuticals, Inc. Vaprisol ® (conivaptan hydrochloride injection) [package insert]. Nashville, TN, April 2014.
- Background: PubMed 20440600Dhar R, Murphy-Human T. A bolus of conivaptan lowers intracranial pressure in a patient with hyponatremia after traumatic brain injury. Neurocrit Care. 2011 Feb;14(1):97-102. doi: 10.1007/s12028-010-9366-x.
- Background: PubMed 11373434Diringer MN, Edwards DF. Admission to a neurologic/neurosurgical intensive care unit is associated with reduced mortality rate after intracerebral hemorrhage. Crit Care Med. 2001 Mar;29(3):635-40. doi: 10.1097/00003246-200103000-00031.
- BackgroundFDA. http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm (2010)
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse J Corry, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conivaptan in people with Cerebral Hemorrhage and Cerebral Edema, run by Jesse Corry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Tolerance of Conivaptan (time frame: Baseline to 168 hours post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000283, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.