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NCT03743805
Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination
EARLY_PHASE1 trial testing Flumazenil in Brain Death. Withdrawn.
20 July 2021
Quick facts
| Lead sponsor | Prisma Health-Midlands |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Start date | 1 January 2019 |
| Primary completion | 20 July 2021 |
| Estimated completion | 21 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Flumazenil (FLUMAZENIL) — full drug profile →
- Naloxone (NALOXONE) — full drug profile →
Conditions studied
- Brain Death — all drugs for Brain Death →
- Anoxic Brain Injury — all drugs for Anoxic Brain Injury →
- Cardiac Arrest — all drugs for Cardiac Arrest →
- Sedative Intoxication — all drugs for Sedative Intoxication →
Sponsor
Prisma Health-Midlands — full company profile →
Who can join
18 and older, any sex, with Brain Death or Anoxic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Current standard of care prior to determination of brain death in subjects with suspected anoxic brain injury is to exclude complicating medical conditions that may confound clinical assessment (such as severe electrolyte, acid base, endocrine or circulatory disturbance), achieve normothermia and normal systolic blood pressure over 100 mmHg (with or without vasopressor use), exclude the presence of neuromuscular blocking agents (with the presence of a train of 4 twitches with maximal ulnar nerve stimulation) as well as to exclude the presence of CNS depressant drug effects. At the present time the latter is done by history, drug screen and allowing enough time for paralytic and sedative drugs to be metabolized and cleared from the body. Clearance is calculated by using 5 times the drug's half-life assuming normal hepatic and renal functions. Half-life can also be prolonged in subjects who have been treated with induced hypothermia. Literature search revealed articles with general guidelines and approaches to brain death, but none addressed pharmacological reversal of sedative drugs
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03743805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Flumazenil
Trials testing the same drug.
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- NCT05681377 — Impact of Flumazenil on the Emergence Delirium · Phase 4 · completed
- NCT06513923 — Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia · Phase 4 · completed
- NCT05397886 — Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation · NA · completed
Other recruiting trials for Brain Death
Currently open trials in the same condition.
- NCT06640088 — Determining ICU Staffs Conceptions, Opinions, Views, Experiences and Reflection of Brain Death and Organ Donation · recruiting
Other Prisma Health-Midlands trials
Trials by the same sponsor.
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- NCT05138549 — Astaxanthin for Management of Inflammation in Knee Osteoarthritis · Phase 2, PHASE3 · terminated
- NCT04771741 — Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03743805 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prisma Health-Midlands
- Last refreshed: 31 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03743805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing