Phase 1/2a Study of Intra-thrombus Plasmin (Human) in Acute Stroke
Research type
Research Study
Full title
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke
IRAS ID
34791
Contact name
Keith Muir
Sponsor organisation
Talecris Biotherapeutics Inc
Eudract number
2009-012086-66
Research summary
Stroke is the third largest cause of death in the UK and the largest cause of adult disability. Most strokes result from blockage of an artery supplying blood to part of the brain by a blood clot ("ischaemic stroke"). Loss of blood supply starves cells of oxygen and nutrients, resulting in permanent damage to the brain. "Clot-busting" (thrombolytic) drugs, when given within a few hours, can restore blood flow and limit damage, with a much improved chance of patients recovering. However, treatment is currently limited to people who can be treated within 4.5 hours of onset, and carries a risk of bleeding, which can be serious. In this study we will test a naturally occurring clot-dissolving protein called Plasmin in patients who have had a stroke caused by a blood clot in a main artery (the Middle Cerebral Artery, MCA), between 4.5 and 9 hours after the onset (i.e. at a time when current treatment cannot be used). Plasmin is made from human blood donations and its properties suggest that it may be both more effective and safer than existing treatments. It is given directly into the clot through a catheter (plastic tube) passed around the circulation to the middle cerebral artery from a blood vessel in the groin. Up to three different doses will be tested, all of which might be effective. The study will test safety by looking for bleeding problems, both clinically and on brain scans, and also assess how well different doses restore blood flow in the blocked artery.
REC name
Scotland A REC
REC reference
09/MRE00/91
Date of REC Opinion
10 Feb 2010
REC opinion
Further Information Favourable Opinion