OBJECTIVE: To determine whether two low dose aprotinin regimens produce clinically significant reductions in postoperative blood loss compared with a control group. DESIGN: A randomised double blind placebo controlled study. SETTING:A regional cardiothoracic unit in London. PATIENTS: 79 patients were consecutively allocated to one of three groups. All patients had primary elective surgery with standard anaesthetic and surgical techniques, and no patients were withdrawn from the study. INTERVENTIONS: Group K patients (n = 27) received aprotinin (10(6) kallikrein inactivator units (KIU) into the pump prime whereas group L patients (n = 27) received an intravenous bolus of aprotinin (0.5 x 10(6) KIU) after induction of anaesthesia and 10(6) KIU was added to the pump prime. A third group (group J, n = 25) received 0.9% saline placebo. MAIN OUTCOME MEASURES: After insertion of the chest drains at the end of cardiopulmonary bypass, blood losses were measured hourly until the drains were removed 18 to 24 h later. Total haemoglobin loss into the chest drains was calculated. RESULTS: Both aprotinin treated groups showed significantly less postoperative blood loss than controls (medians: group K, 400 ml; group L, 400 ml; v controls 780 ml; p < 0.001) and there was even less measured postoperative haemoglobin loss within the chest drains in both the aprotinin treated groups than in the controls (medians: group K, 16 g; group L, 19 g; v controls, 47 g; p < 0.001). CONCLUSION: In primary cardiac surgery the dose of aprotinin may be reduced by about 80% from the recommended high dose schedule and still significantly reduce postoperative blood loss compared with placebo.
RCT Entities:
OBJECTIVE: To determine whether two low dose aprotinin regimens produce clinically significant reductions in postoperative blood loss compared with a control group. DESIGN: A randomised double blind placebo controlled study. SETTING: A regional cardiothoracic unit in London. PATIENTS: 79 patients were consecutively allocated to one of three groups. All patients had primary elective surgery with standard anaesthetic and surgical techniques, and no patients were withdrawn from the study. INTERVENTIONS: Group K patients (n = 27) received aprotinin (10(6) kallikrein inactivator units (KIU) into the pump prime whereas group L patients (n = 27) received an intravenous bolus of aprotinin (0.5 x 10(6) KIU) after induction of anaesthesia and 10(6) KIU was added to the pump prime. A third group (group J, n = 25) received 0.9% saline placebo. MAIN OUTCOME MEASURES: After insertion of the chest drains at the end of cardiopulmonary bypass, blood losses were measured hourly until the drains were removed 18 to 24 h later. Total haemoglobin loss into the chest drains was calculated. RESULTS: Both aprotinin treated groups showed significantly less postoperative blood loss than controls (medians: group K, 400 ml; group L, 400 ml; v controls 780 ml; p < 0.001) and there was even less measured postoperative haemoglobin loss within the chest drains in both the aprotinin treated groups than in the controls (medians: group K, 16 g; group L, 19 g; v controls, 47 g; p < 0.001). CONCLUSION: In primary cardiac surgery the dose of aprotinin may be reduced by about 80% from the recommended high dose schedule and still significantly reduce postoperative blood loss compared with placebo.
Authors: A A de Smet; M C Joen; W van Oeveren; K J Roozendaal; M P Harder; L Eijsman; C R Wildevuur Journal: J Thorac Cardiovasc Surg Date: 1990-10 Impact factor: 5.209
Authors: A Locatelli; P Ceriana; M Maurelli; D Bertollo; T Bianchi; M P Mazza; G Chiaudani; A Pagnin Journal: Lancet Date: 1991-07-27 Impact factor: 79.321
Authors: M Havel; H Teufelsbauer; P Knöbl; R Dalmatiner; P Jaksch; W Zwölfer; M Müller; T Vukovich Journal: J Thorac Cardiovasc Surg Date: 1991-06 Impact factor: 5.209
Authors: W Dietrich; M Spannagl; M Jochum; P Wendt; W Schramm; A Barankay; F Sebening; J A Richter Journal: Anesthesiology Date: 1990-12 Impact factor: 7.892