BACKGROUND:Anemia may be an important factor contributing to an increased risk of bleeding, particularly in patients with thrombocytopenia.
STUDY DESIGN AND METHODS:A multicenter, single-blinded pilot randomized controlled trial (RCT) was performed to evaluate the feasibility of conducting a larger RCT to determine the effect of the hemoglobin (Hb) concentration on bleeding risk. Patients with acute leukemia receiving induction chemotherapy or those undergoing stem cell transplantation were assigned to one of two treatment groups: standard transfusion strategy (transfusion of 2 units of red blood cells [RBCs] when their Hb level was less than 80 g/L) or an augmented transfusion strategy (transfusion of 2 units of RBCs when their Hb level was less than 120 g/L). RESULTS: Sixty patients were enrolled: 29 in the control group and 31 in the experimental group. The proportions of patients experiencing clinically significant bleeding and the time to first bleed were not significantly different between the control and experimental groups. The experimental group received more RBC transfusions (transfusions/patient-day) than the control group (0.233 vs. 0.151; relative risk, 1.56; 95% confidence interval, 1.16-2.10; p = 0.003). The proportion of patient-days with platelet (PLT) transfusions was not different between the experimental and control groups. The mean number of donor exposures (PLT and RBC transfusions) was not different between experimental and control groups. Bleeding symptoms were systematically documented. CONCLUSION: This pilot study thus indicated that it would be feasible to enroll the required number of patients to enable the performance of a large RCT to investigate the effect of Hb on bleeding risk in thrombocytopenic patients. P atients with acute leukemia undergoing induction chemotherapy or patients undergoing stem cell transplantation (SCT) often have prolonged thrombocytopenia both because of the cytotoxic therapies they receive and because of their underlying disorders. The relationship between bleeding and thrombocytopenia has been well described, and bleeding is a frequent complication occurring in this patient population.1-8 Despite the administration of prophylactic or therapeutic platelet (PLT) transfusions, these patients are still at risk of bleeding.Experimental evidence in animal models suggests that the hemoglobin (Hb) concentration may play a role in determining the bleeding risk in patients with thrombocytopenia. In contrast, other groups have suggested that ABBREVIATIONS: AML = acute myeloid leukemia; RCT(s) = randomized controlled trial(s); RR(s) = relative risk(s). acute hemodilution may increase coagulation. 9,10 With a thrombocytopenic rabbit model, Blajchman and coworkers 11 demonstrated the bleeding time to be inversely correlated with the hematocrit (Hct). This study showed that increasing the red blood cell (RBC) mass by RBC transfusion partially corrected the bleeding time in thrombocytopenic anemic rabbits. The reasons for this are not clearly understood, but several mec...