Objective The objective of this paper is to present the results from Spiral Pump clinical
trial after design modifications performed at its previous project. This pump
applies axial end centrifugal hydraulic effects for blood pumping during
cardiopulmonary bypass for patients under cardiac surgery. Methods This study was performed in 52 patients (51% males), between 20 to 80 (67±14.4)
years old weighing 53 to 102 (71.7±12.6) kg, mostly under myocardial
revascularization surgery (34.6%) and valvular surgery (32.8%). Besides the
routine evaluation of the data observed in these cases, we monitored pump
rotational speed, blood flow, cardiopulmonary bypass duration, urine free
hemoglobin for blood cell trauma analysis (+ to 4+), lactate desidrogenase (UI/L),
fibrinogen level (mg/dL) and platelet count (nº/mm3). Results Besides maintaining appropriate blood pressure and metabolic parameters it was
also observed that the Free Hemoglobin levels remained normal, with a slight
increase after 90 minutes of cardiopulmonary bypass. The Lactate Dehydrogenase
showed an increase, with medians varying between 550-770 IU/L, whereas the
decrease in Fibrinogen showed medians of 130-100 mg/dl. The number of platelets
showed a slight decrease with the medians ranging from 240,000 to
200,000/mm3. No difficulty was observed during perfusion
terminations, nor were there any immediate deaths, and all patients except one,
were discharged in good condition. CONCLUSION The Spiral Pump, as blood propeller during cardiopulmonary bypass, demonstrated
to be reliable and safe, comprising in a good option as original and national
product for this kind of application.