A multicenter pilot-randomized controlled trial of the feasibility of an augmented red blood cell transfusion strategy for patients treated with induction chemotherapy for acute leukemia or stem cell transplantation. [Acute anemia in high digestive hemorrhage. Margins of security for their handling without transfusion of red globules]. Effect of early blood transfusion on gastrointestinal haemorrhage. Tranexamic acid and upper gastrointestinal haemorrhage--a double-blind trial. [Blood transfusion and survival of patients with neoplasms of the colon and rectum]. Mechanical methods of reducing blood transfusion in cardiac surgery: randomised controlled trial. A prospective, randomized trial limiting perioperative red blood cell transfusions in vascular patients. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. A controlled trial of educational outreach to improve blood transfusion practice.
Anemia may be an important factor contributing to an increased risk of bleeding, particularly in patients with thrombocytopenia.
                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).
                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.
                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. Red cells transfusion in the patient with acute hemorrhage, must be evaluated in a risk/benefit rate context. The present tendencies appoint that the use of the hematocrit "magic" number is unsafe and uncertain to decide a red cell transfusion. We have conducted a prospective randomized and controlled trial in 60 patients with acute digestive hemorrhage without haemodynamic failure. We realized two groups: 1) control group: the target of transfusion in these patients was the hematocrit value of > or = 28%. 2) treatment group: these patients were supported with normovolemic haemodilution with crystalloid solutions until a hematocrit value of 21%. All patients have endoscopic diagnosis and they went evaluated across the study with clinic and laboratory controls. Both groups were significative differences in the hematocrit value. We did not see differences between the groups in the hospital stay neither the rate of organs failure. We find difference between the groups in the amount of red cell units (0.61 +/- 0.87 vs. 2.14 +/- 1.10; treatment and control respectively, P < 0.001). The APACHE score was greater in the treatment group. This supports that the oldest patients, who probably have least physiologic reserve, could be treated without complications. Acute hemorrhage-normovolemic haemodilution-digestive hemorrhage transfusion. The effect of citrated stored blood on coagulation was studied initially in a pilot study where 25 patients with acute severe gastrointestinal haemorrhage had their whole blood coagulation measured using the Biobridge Impedance Clotting Time (ICT). This demonstrated that there is a hypercoagulable response to haemorrhage which was partially reversed by blood transfusion. Similar changes were noted in Kaolin Cephalin Clotting Times (KCCT). A further 50 patients were then randomized to receive, during the 24 h after admission, either at least 2 units of blood or no blood transfusion unless the haemoglobin fell below 8 g/dl or they were shocked. In the transfused group nine patients re-bled compared with only one in the non-transfused group (P less than 0.01, chi 2 with Yates' correction). Early blood transfusion appears to reverse the hypercoagulable response to haemorrhage thereby encouraging re-bleeding and hence the need for an operation. The efficacy of antifibrinolytic therapy in the management of acute upper gastrointestinal haemorrhage has been investigated in a double-blind clinical trial. Two-hundred patients were studied using tranexamic acid, a potent antifibrinolytic agent. Of these, 103 were in the treatment group and 97 in the control group. Patients were analysed to determine severity of initial blood loss, transfusion requirements, together with the incidence of recurrent bleeding, surgical intervention, and death. Final diagnosis as to the site of bleeding was arrived at using endoscopy, barium studies, and the findings at operation and necropsy. The groups were well matched as regards severity of initial haemorrhage, age, sex, aetiological diagnosis, and precipitating factors. A significant difference was observed in the requirement for surgical intervention to control continuing or recurrent haemorrhage. Twenty-three of 97 in the control group and seven of 103 in the treatment group required surgery. There appeared to be a reduction in the transfusion rate after the first three days of hospitalization in the treatment group. There were no significant differences in mortality or in side-effects between the two groups. The fate of 248 patients diagnosed of colorectal malignancies between 1973 and 1982 and subjected to radical surgery with curative purposes was analysed. The effect of peroperative whole blood and packed red cells transfusions, along with other co-variants, on the survival of the patients was studied. It was found, by means of the Cox analysis, that whole blood and the Duke's staging system had the most important correlation (p = 0.003 and p = 0.02, respectively) on the patients' prognosis and survival, no such relationship being found with packed red cells transfusion (p = 0.25). Dose-related association between the relapse index and the number of whole blood units transfused was shown by the Mantel's global trend test (p = 0.015). The different effect of the transfusion products would confirm the hypothesis that the relationship between transfusion and poorer prognosis, thought to be due to patient's immunosuppression and hence higher relapse index, could be determined by any ill-defined plasmatic factor. To assess the effectiveness of two mechanical methods of blood conservation in reducing the need for allogeneic red blood cells or coagulation products during cardiac surgery.
                Randomised controlled trial.
                Regional cardiac centre in a teaching hospital in Southampton.
                263 adults aged 18-80 years undergoing elective coronary artery bypass surgery entered the study, of whom 252 completed the trial. All patients received routine perioperative care. Patients were allocated to one of three treatment groups: intraoperative cell salvage, intraoperative cell salvage with acute perioperative normovolaemic haemodilution, or no mechanical blood conservation. There were 84 patients in each group.
                Numbers of patients who received allogeneic blood or coagulation products, and the mean number of units of blood transfused per patient.
                Of the patients in the intraoperative cell salvage group, 26 were given a transfusion of allogeneic blood, compared with 43 in the control group (odds ratio 0.43 (95% confidence interval 0.23 to 0.80)). The mean number of units of allogeneic blood transfused per patient in the intraoperative cell salvage group was 0.68 units (SD=1.55), compared with 1.07 (1.56) units in the control group. 32 of the patients in the intraoperative cell salvage group were given any blood product, compared with 47 in the control group (odds ratio 0.47 (0.25 to 0.89); P=0.019). Combining acute perioperative normovolaemic haemodilution with intraoperative cell salvage conferred no additional benefits.
                An intraoperative cell salvage device should be used in elective coronary artery bypass grafting. Pharmacological strategies may achieve further reductions in blood transfusions. Yet further reductions in blood transfusions could be achieved if the lower safe limit of haemoglobin concentration in patients undergoing cardiac surgery were known. Patients undergoing major arterial reconstruction have traditionally been transfused with red blood cells to keep hemoglobin concentrations above 10 g/dL in order to prevent anemia-induced myocardial ischemia. There are no data to support this practice. The hypothesis that vascular patients will tolerate a hemoglobin concentration of 9 g/dL was examined.
                Ninety-nine patients undergoing elective aortic and infrainguinal arterial reconstructions were prospectively randomized preoperatively to receive transfusions to maintain a hemoglobin level of either 10 g/dL or 9 g/dL.
                Despite significantly different postoperative hemoglobin levels of 11.0 +/- 1.2 versus 9.8 +/- 1.3 g/dL (P <0.0001), there were no differences in mortality or cardiac morbidity rates or length of hospital stay. There were no differences in hemodynamic parameters. Oxygen delivery was lower in the group with lower hemoglobin levels, but there was no difference in O2 consumption between the groups.
                A lower hemoglobin concentration was tolerated without adverse clinical outcome. Patients did not compensate for anemia by increased myocardial work, but by increasing O2 extraction in the peripheral tissues. Uncontrolled bleeding is a leading cause of death in trauma. Two randomized, placebo-controlled, double-blind trials (one in blunt trauma and one in penetrating trauma) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa (rFVIIa) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma.
                Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 microg/kg) or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell (RBC) unit, with additional doses 1 and 3 hours later. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose.
                Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups.
                Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range. To determine whether brief, face-to-face educational outreach visits can improve the appropriateness of blood product utilization.
                Randomized, controlled multicenter trial with 6-month follow-up.
                Surgical and medical services of two pairs of matched community and teaching hospitals in Massachusetts.
                One hundred one transfusing staff surgeons and attending medical physicians.
                A professionally based transfusion specialist presented one surgical- or medical-service-wide lecture emphasizing appropriate indications, risks, and benefits of red blood cell transfusions; brief, graphic, printed educational guidelines; and one 30-minute visit with each transfusing physician. No data feedback was provided. Educational messages emphasized the lack of utility of the traditional threshold for red blood cell transfusions (hematocrit, 30%) and transfusion risks (eg, viral hepatitis).
                Proportion of red blood cell transfusions classified as compliant or noncompliant with blood transfusion guidelines, or indeterminate 6 months before and 6 months after an experimental educational intervention.
                Based on analyses of 1449 medical record audits of red blood cell transfusions that occurred 6 months before and 6 months after the educational intervention, the average proportion of transfusions not in compliance with criteria declined from 0.40 to 0.24 among study surgeons (-40%) compared with an increase from 0.40 to 0.44 (+9%) among control surgeons (P = .006). These effects were consistent across procedure type and specialty. On average, study surgeons in the postintervention period performed transfusions when hematocrits were 2.0 percentage points lower than before the intervention (28.3% preintervention vs 26.3% postintervention), and lower than in the control group (28.3% preintervention and postintervention; P = .04). Likely savings in blood use for surgical services probably exceeded program costs, even without considering reduced risks of infection. No effects were observed among transfusions occurring in medical services, possibly because of substantially lower transfusion rates and lower pretransfusion hematocrits.
                Brief, focused educational outreach visits by transfusion specialists can substantially improve the appropriateness and cost-effectiveness of blood product use in surgery. More data are needed regarding the durability of changes in practice patterns and the health and economic benefits of such interventions.
There were more deaths and more rebleeding in the transfusion arms of the combined studies, but the small numbers of participants and large volume of missing data limit the significance of the findings. The studies in this review do not provide useful data regarding outcomes following red blood cell transfusion for acute upper gastrointestinal haemorrhage. They appear to exclude large survival benefit. Large, well-concealed RCTs of sufficient power are urgently needed.