1994 年 40 巻 1 号 p. 1-13
Sixty-six patients who succeeded in storing a sufficient volume of autologous blood (mean±SD; 1097±452ml) using KL-3R3 solution contained in blood bags before elective surgery were included in this study, a five week phase 3 clinical trial of the whole blood preservative solution KL-3R3, commonly known as CPDA-1 (citrate phosphate dextrose adenine) solution. The mean time required for sufficient storage of autologous blood was 23.4±6.9 days, with 40 of the 66 (60.6%) requiring more than 21 days, a period of time that would have resulted in time expiration had we used the citrate-phosphate-dextrose (CPD) or acid-citrate-dextrose (ACD) solution bags which are presently commercially available. Sixty of the 66 patients (90.9%) completed their operations using only autologous blood units. After eliminating three patients who were administered recombinant erythropoietin, the efficacy of KL-3R3 was evaluated as effective in 61 (96.8%) of the 63 patients evaluated (markedly effective 57 (86.4%) and effective 4 (6.1%). Furthermore, in 48 of 56 patients (85.7%), in whom we were able to measure the autologous blood recovery rate after 24 hours of transfusion were estimated effective (markedly effective 29 (51.8%) and effective 19 (33.9%)). In sixty-three patients who had hematological and biochemical laboratory data, vital signs, and urinary data recorded both before and after receiving autologous blood units. RBC counts and hemoglobin levels and platelets counts decreased, and WBC counts increased after returning autologous blood at operation, changes observed commonly under surgical stress. Hemolysis markers such as GPT, indirect bilirubin, and LDH were slightly increased the day after operation, but returned to normal the second day after operation. Other data moved within normal limits expect urine occult blood. Hematuria was observed immediately after transfusion of autologous blood units, but this finding was observed transiently (the first day after transfusion 45.7% and the second day 13.3%). The safety was evaluated in sixty-five patients' blood bags by sight observations and bacterial culture tests, and no abnormal findings or bacterial propagation were detected. One patient was excluded from the safety evaluation because he was operated on within a week of initial predeposition. Two-hundred-thirty-eight KL-3R3 preserved blood bags were transfused in the 66 patients, in one (1/238, 0.4%) which had be discarded because of a large clot formation. In sixty-one patients, both the efficacy and the safety tests of KL-3R3 were rated for usefulness, with all 61 confirmed useful. The laboratory data of the 26 patients whose autologous blood were used within 21 days and the 40 patients whose autologous blood contained at least one unit that exceeded 21 days preservation was compared, with no significant differences observed.
Our results confirmed that, in clinical trial of KL-3R3 preserved autologous blood units, all the criteria of effectiveness, safety and usefulness were satisfied.