Trials / Unknown
UnknownNCT03463551
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- NHS Greater Glasgow and Clyde · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Detailed description
Only a small proportion of patients are currently suitable for treatment with "clot busting" drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more people to be treated. Currently available methods require extra time to acquire and are not therefore widely used. By carrying significant extra oxygen to the brain, the ABL-101 molecule may not only allow the visualisation of salvageable tissue, but also prevent progression of stroke damage in and have an additional direct benefit on tissue survival. Studies in animal models of stroke show smaller areas of stroke damage after ABL-101. There is therefore a rationale for testing this molecule in stroke patients, both as a diagnostic method, and also as a potential therapeutic agent.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABL-101 | ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration. |
| OTHER | 0.9% NaCl | Placebo |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2019-09-01
- Completion
- 2020-03-01
- First posted
- 2018-03-13
- Last updated
- 2018-08-02
Source: ClinicalTrials.gov record NCT03463551. Inclusion in this directory is not an endorsement.