First Human Clinical Investigation of the Next Generation Self-Assembling Haemostat [in progress]
The clinical investigation ‘First-in-Human Trial of the Safety and Performance of NU-MAX® as a Hemostatic Agent in Intracranial Neurosurgery’ with the next generation self-assembling peptide is currently live.
ClinicalTrials.gov Identifier: NCT04953949
Haemostasis is a necessity in neurosurgery to keep adequate visual control during the operation and to prevent postoperative haemorrhage. Topical haemostats in neurosurgery are typically either chemically active or mechanical sealants. These ‘new generation’ self-assembling peptides have beneficial properties making them potentially well suited for use as neurosurgical haemostats. They need no special preparation prior to use. They have no known interaction with the body’s own coagulation system. They do not expand in volume. They form a transparent hydrogel, thus maintaining visibility of the surgical field.
The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX when used as a topical haemostat for oozing bleeding encountered during neurosurgical intracranial procedures, in which control of bleeding by conventional haemostatic techniques is either ineffective or impractical.
Phase I recruitment of the first 10 patients conducted at the lead site in Belgium is now complete. Phase II will be set to start recruitment after 3 months. The ethical approvals have been granted for the UK sites to enter phase II. A total of 80 patients will be recruited for this clinical trial across up to 6 sites.