Efficacy of UVC-treated, pathogen-reduced platelets versus untreated platelets: a randomized controlled non-inferiority trial
Pathogen reduction (PR) technologies for blood components have been established to reduce the residual risk of known and emerging infectious agents. THERAFLEX UVPlatelets, a novel UVC light-based PR technology for platelet concentrates, works without photoactive substances. This randomized, controlled, double-blind, multicenter, noninferiority trial was designed to compare the efficacy and safety of UVC-treated platelets to that of untreated platelets in thrombocytopenic patients with hematologic-oncologic diseases. Primary objective was to determine non-inferiority of UVC-treated platelets, assessed by the 1-hour corrected count increment (CCI) in up to eight per-protocol platelet transfusion episodes. Analysis of the 171 eligible patients showed that the defined non-inferiority margin of 30% of UVC-treated platelets was narrowly missed as the mean differences in 1-hour CCI between standard platelets versus UVC-treated platelets for intention-to-treat and perprotocol analyses were 18.2% (95% confidence interval [CI]: 6.4%; 30.1) and 18.7% (95% CI: 6.3%; 31.1%), respectively. In comparison to the control, the UVC group had a 19.2% lower mean 24-hour CCI and was treated with an about 25% higher number of platelet units, but the average number of days to next platelet transfusion did not differ significantly between both treatment groups. The frequency of low-grade adverse events was slightly higher in the UVC group and the frequencies of refractoriness to platelet transfusion, platelet alloimmunization, severe bleeding events, and red blood cell transfusions were comparable between groups. Our study suggests that transfusion of pathogen-reduced platelets produced with the UVC technology is safe but non-inferiority was not demonstrated. (The German Clinical Trials Register number: DRKS00011156).
Intra-patient variability of thromboelastographic parameters following in vivo and ex vivo administration of recombinant activated factor VII in haemophilia patients. A multi-centre, randomised trial
Thrombosis and Haemostasis. 2010;103((2):):351-9.
Thromboelastography methods have been used to predict or monitor treatment of haemophilia patients with recombinant activated factor VII (rFVIIa). However, neither of the two thromboelastographic methods (ROTEM and TEG) has as yet been validated. This multi-centre, randomised trial compared both methods in terms of intra- and inter- patient variability following in vivo and ex vivo rFVIIa administration to haemophilia A and B patients with and without inhibitors. Patients ((3)16 years old) received the same intravenous rFVIIa dose (45, 90 or 180 microg/kg) twice, 1-12 weeks apart. Blood samples were collected pre-dose and 15, 60, 120 and 240 minutes post-dose for ROTEM and TEG analysis. Pre-dose samples were also spiked ex vivo with rFVIIa (0. 6, 1. 2 or 2. 4 microg/ml), to correspond to the three in vivo doses. Twenty-six haemophilia A and four haemophilia B patients were enrolled. A significant treatment effect was observed with in vivo rFVIIa (p<0. 05) with more pronounced effects in inhibitor (n=14) versus non-inhibitor (n=16) patients. There was a strong positive correlation between ROTEM and TEG parameters. Intra- and inter-patient variation was large for all thromboelastography parameters at all time points and rFVIIa doses. Intra-patient variation was generally lower for non-inhibitor than inhibitor patients, and lower following ex vivo spiking versus in vivo rFVIIa administration. In conclusion, there was a clear effect of rFVIIa on all thromboelastography parameters, but the large intra- and inter-patient variability following in vivo rFVIIa administration renders the use of our method unsuitable for dose-response prediction for haemophilia patients in the clinical setting.
The effects of infusion methods on platelet count, morphology, and corrected count increment in children with cancer: in vitro and in vivo studies
Oncology Nursing Forum. 1994;21((10):):1669-73.
PURPOSE/OBJECTIVES To determine whether infusion method influences the quality of platelets transfused. DESIGN Linked in vitro and in vivo study. Quasi-experimental design for in vitro and cross-over design with balanced randomization for in vivo. SETTING Pediatric cancer center in the midsouthern United States. SAMPLE Pheresed/pooled platelet units in vitro (n = 12). In vivo convenience sample of 26 children, ages 2-19 years, with cancer and thrombocytopenia who required platelet transfusion. METHODS Two infusion pumps (IMED 980 and Gemini, IMED Corp., San Diego, CA) versus gravity flow for in vitro platelet infusion. Gemini infusion pump versus gravity flow for in vivo platelet transfusion. MAIN OUTCOME MEASURES Platelet count, morphology score, and corrected count increment. FINDINGS No significant differences noted in platelet count or morphology score among or across the three infusion methods in vitro. No significant differences noted between the two infusion methods in platelet count or corrected count increment in vivo. CONCLUSIONS Although limited to a specific patient population, setting, and infusion device, findings revealed that the pump was clinically acceptable because it did not negatively affect platelet recovery. Replication of this study with other infusion devices is recommended. IMPLICATIONS FOR NURSING PRACTICE Study findings validate the current nursing procedure for the administration of platelets at the study setting. Use of infusion pumps for platelet transfusions is time-efficient and energy-efficient for nurses because the pumps offer a well-controlled infusion rate, accurate volume measurement, and an alarm system for monitoring the infusion.
Effect of blood transfusion on in vivo levels of plasma fibronectin
Journal of Laboratory & Clinical Medicine. 1981;98((3):):336-41.
Fibronectin, an opsonic glycoprotein, is known to bind fibrinogen and fibrin. Microaggregate debris contained in stored bank blood is composed of degenerating platelets, leukocytes, and fibrin strands. The debris ranges in size from 10 to 160 micrometers. This study examined the effect of transfusion of 2 units of stored red blood cells, containing varying amounts of macroaggregate debris, on in vivo levels of fibronectin. Anemic outpatients were selected at random to receive blood transfusion through either a 170 micrometer standard blood filter or one of four microaggregate filters. A sixth group received saline-washed red blood cells. Results showed that the greatest drop in posttransfusion levels of fibronectin (39 microgram/ml) were found in the group that received blood through a 170 micrometer standard filter and thus received the greatest amount of microaggregate debris (p less than 0.05; N = 50). The patients who received the least microaggregate debris, those receiving washed red cells, showed the smallest decrease in posttransfusion levels of fibronectin (9 microgram/ml); this decrease was not significant (p greater than 0.05; N = 50). Patients receiving blood through 20 to 25 micrometer microaggregate blood filters showed a fall in posttransfusion levels of fibronectin (10 to 15 microgram/ml) intermediate between that found for the two groups described above; this decrease was not significant (p greater than 0.05; N = 35). The decrease in posttransfusion levels of fibronectin found after administration of blood through a 40 micrometer microaggregate screen filter (31 microgram/ml) was significantly different from pretransfusion levels (p less than 0.05; N = 20). Data obtained from this study suggest that transfusion of the microaggregate debris contained in 2 units of stored bank blood can lower in vivo levels of fibronectin. We conclude that if maintaining high levels of fibronectin is shown to be of value in the treatment of critically ill patients, removal of microaggregate debris from any blood transfusions required by these patients would be warranted.