RESUMO
1. In order to accredit the NISR440 Polycarbonate Membrane for clinical studies, the following was accomplished and/or established: a. Casting and synthesis were increased from the laboratory level to production scale. b. Quality control of permeabilities and physical properties was within +/- 5%, from membrane lot to lot and within the same roll. c. The target properties of the Artificial Kidney Program (NIH) were reached(7): 1) Middle M. W. solute permeability of marked molecules was established by 3 different laboratories and averaged: Vitamin B12 - 296 x Cuprophan¿; Inulin 3.6 x Cuprophan¿; Bacitracin 2.94 x Cuprophan¿. 2) Low M. W. species permeabilities were approximately the same as Cuprophan¿, to avoid a depletion syndrome. 3) Hydraulic permeability was essentially the same as Cuprophan¿ (UF rate 1.25 to 2.0 x Cuprophan¿) to avoid dehydration and hypotension. 4) Burst strength was 1.5 to 2.0 x Cuprophan¿. d. Toxicology studies were all negative in spot and in serial lot testing. e. Non-thrombogenicity tests (Lindholm test) were up to 36.6% better than Cuprophan¿. f. No protein adsorption was found. g. The membrane could be produced in the wet and dry state with the same permeability and physical properties. 2. In an earlier clinical study at USC, it was established that: a. There were no toxic effects manifested in patients in 25 episodic studies. b. Clearances forlow M. W. solutes and hydraulic permeabilities were, as targeted, approximately the same as Cuprophan¿. c. In 4 1/2 mos of a double blind study of 6 patients, no significant toxic effects were noted for either the patients on Cuprophan¿ or NISR 440 Polycarbonate Membrane. Two patients had an increase of hematocrit. 3. The ability to heat seal the membrane in the periphery and in channels through many layers, combined with its relative rigidity when wet, make possible clinical hemodialyzer designs approximately the size of a package of cigarettes and inexpensive to produce.
