An expanded access record providing Sorin XTRA/Sorin Group, in Autologous Blood Transfusion, sponsored by Beijing Anzhen Hospital. Temporarily not available at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Beijing Anzhen Hospital · Expanded access
Perioperative blood loss continues to be a serious problem in complex aortic arch surgery using deep hypothermic circulatory arrest (DHCA). Major blood loss causes increased morbidity and mortality [1]. These patients often require transfusion of allogeneic blood products. It has been estimated shortages of blood supply in China will worsen [2]. Clinicians have made significant progress to decrease the quality of allogenic blood transfusion.
Increasing postoperative hemorrhage risk of aortic arch patients undergoing DHCA may be related to CPB induced hemostatic defect, the use of the CPB is likely to contribute to coagulation factor lost and platelet dysfunction [3, 4]. We are aware of the potential benefit of aPRP, withdrawal of aPRP immediately before initiating CPB appears to be a promising approach because it avoids CPB-related platelet damage and limits post-CPB blood loss. So we adopted and used aPRP as a blood conservation technique to reduce blood transfusion in aortic arch surgery with DHCA. Autologous red blood cells were infused to maintain a HGB level above 100 g/L after heparin neutralizing activity. And aPRPs were transfused after heparin neutralizing activity as no active bleeding was observed. Our goal was to determine the effect between aPRP and homologous transfusion on perioperative bleeding during complex aortic arch surgery using DHCA.
Autologous Platelet-Rich Plasma Harvest Technique In the treatment group, shortly after administration of general anesthesia, blood was collected via central venous catheter 60 ml per minute (that was proven to be safe) and approximately 15-20 mL/kg of whole blood was collected. The harvested blood was then centrifuged at 2400 rpm to separate the red blood cells (RBC) from the autologous platelet rich plasma (aPRP). The separated blood component was processed by acid sodium citrate glucose solution (AcD-A) for anti-coagulation. No systemic heparin was administered at this time. The aPRP component was then stored at 20℃ - 24℃. When the blood withdrawal was proceeding, lactated ringer's solution and succinylated gelatin were used via the peripheral vein to dilate circulating capacity and maintain hemodynamic stability. A vasoactive drug was used if necessary. The systematic heparinization began after blood collection had completed. General blood salvage was performed during surgery and transfused according to the patient's actual intraoperative needs.
The mean quantity of whole blood collected for Autologous Platelet-Rich Plasma Harvest was 1037 ± 286 mL. The control group was only subjected to general intraoperative blood conservation using red blood cell salvage and allogenic blood transfusion.
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Beijing Anzhen Hospital