The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.
Effect of intraoperative cell rescue on bleeding related indexes after cesarean section
World journal of clinical cases. 2022;10(8):2439-2446
BACKGROUND Obstetric hemorrhage is the leading cause of maternal mortality globally, especially in China. The key to a successful rescue is immediate and rapid blood transfusion. Autotransfusion has become an integral part of clinical blood transfusion, with intraoperative cell salvage (IOCS) being the most widely used. AIM: To investigate the application of IOCS in cesarean section. METHODS A total of 87 patients who underwent cesarean section and blood transfusion in our hospital from March 2015 to June 2020 were included in this prospective controlled study. They were divided into the observation (43 cases) and control (44 cases) groups using the random number table method. The patients in both groups underwent lower-segment cesarean section. The patients in the control group were treated with traditional allogeneic blood transfusion, whereas those in the observation group were treated with IOCS. Hemorheology [Red blood cell count, platelet volume, and fibrinogen (FIB)] and coagulation function (partial prothrombin time, prothrombin time (PT), platelet count, and activated coagula-tion time) were measured before and 24 h after transfusion. In the two groups, adverse reactions, such as choking and dyspnea, within 2 h after cesarean section were observed. RESULTS Before and after transfusion, no significant differences in hemorheology and coagulation function indices between the two groups were observed (P > 0.05). About 24 h after transfusion, the erythrocyte count, platelet ratio, and FIB value significantly decreased in the two groups (P < 0.05); the PLT value significantly decreased in the two groups; the activated partial thromboplastin time, PT, and activated clotting time significantly increased in the two groups (P < 0.05); and no statistical differences were observed in hemorheology and coagulation function indices between the two groups (P > 0.05). Furthermore, there was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). CONCLUSION In patients undergoing cesarean section, intraoperative cell salvage has a minimum effect on hemorheology and coagulation function and does not increase the risk of amniotic fluid embolism.
Intraoperative Cell Salvage for Women at High Risk of Postpartum Hemorrhage During Cesarean Section: a Systematic Review and Meta-analysis
Reproductive sciences (Thousand Oaks, Calif.). 2022
Postpartum hemorrhage (PPH) can lead to substantial blood loss that compromises maternal hemodynamic stability and consequently cause severe maternal complications such as organ dysfunction or death. Intraoperative cell salvage (IOCS), an effective method of blood conservation used in other surgical specialties, can be an alternative intervention for managing PPH. Thus, our aim was to evaluate the efficacy and safety of IOCS for women at high risk of PPH undergoing cesarean sections. We conducted a systematic search of electronic databases from inception to February 25, 2021 for randomized controlled studies and observational studies published in English or Mandarin about IOCS use in cesarean sections. Primary outcomes of interest were changes in postoperative hematologic parameters and any adverse events reported among patients that had IOCS and controls that had an allogeneic blood transfusion. The certainty of the evidence of the outcomes was evaluated using the GRADE approach. A total of 24 studies with 5872 patients were included in the meta-analysis. Eleven randomized controlled trials (RCTs), and 13 observational studies were analyzed. Postoperative hemoglobin levels were higher among patients with IOCS SMD 0.39 (95% CI; 0.20, 0.60; P < 0.001, high certainty). Allogeneic blood transfusion increased adverse events RR = 1.81(95% CI; 1.24, 2.62; P = 0.002, low certainty). IOCS shortened hospital stay SMD - 0.59 (95% CI: - 0.98, - 0.19; P = 0.004, low certainty) and shortened prothrombin time SMD - 0.67 (95% CI; - 1.31, - 0.04), P = 0.037, low certainty). The lower incidence of transfusion-related adverse events and shorter hospital stay among other findings demonstrate that IOCS use in obstetrics is an effective and safe alternative for the management of PPH; however, high-quality randomized control studies are required to confirm this evidence.
Intraoperative cell salvage as an effective intervention for postpartum hemorrhage-Evidence from a prospective randomized controlled trial
Frontiers in Immunology. 2022;13:953334
BACKGROUND Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality. Promptly recovering blood loss is critical for PPH. Intraoperative cell salvage (ICS) is a method to collect and process red blood cells (RBCs) from the blood lost during surgery and transfuse them to the patient's circulation during or immediately after surgery. Its effectiveness in reducing the demand for allogeneic blood transfusion has been proven, but its effectiveness and safety as a sole treatment for PPH during Cesarean sections are unclear. This is particularly important for patients who cannot or do not want to accept allogeneic blood transfusion. MATERIALS AND METHODS In this prospective randomized controlled study, patients with high risks of PPH were randomized into the ICS group or the control group, receiving ICS or allogeneic RBC transfusion if their hemoglobin level was less than 80 g/L during operation. Data collected include clinical examination, blood cell count, hemoglobin level, coagulation function, and plasma levels of fetal hemoglobin, tissue factor, and alpha-fetoprotein before and after fetal delivery and 0, 2, and 12 h after treatment. Adverse events were recorded. RESULTS A total of 130 patients were enrolled, aged 33 ± 1 years with a mean gestation period of 37 ± 1 week. The most common cause of Cesarean section was placenta previa, followed by twin pregnancy, scarred uterus, preeclampsia, placental abruption, fetal distress, and placenta accreta spectrum. Bleeding amount was similar between the two groups. The ICS group, compared to controls, had more efficient increases in levels of hemoglobin, RBC, and hematocrit (all p < 0.05). Coagulation function was maintained in the ICS group but reduced in controls 24 h after transfusion, indicated by significantly reduced fibrinogen level and prolonged prothrombin time (PT), thrombin time (TT), and activated partial thromboplastin time (aPTT) (all p < 0.05). There was a transient but significant decrease in plasma tissue factor and alpha-fetoprotein levels and an increase in plasma fetal hemoglobin level with ICS treatment in the postpartum period. No adverse event occurred with ICS intervention. CONCLUSION ICS is an effective and safe intervention for patients with a high risk of PPH during elective or emergency Cesarean section. It can effectively clear tissue factors and alpha-fetoprotein but not fetal hemoglobin.
Comparison of cell salvage with one and two suction devices during cesarean section in patients with placenta previa and/or accrete: a randomized controlled trial
Chinese medical journal. 2020
BACKGROUND Cell salvage has recently been recommended for obstetric use in cases with a high risk of massive hemorrhage during cesarean section (CS). However, limited data are available to support the use of one suction device to collect lost blood. This study aimed to investigate the volume of red blood cells (RBCs) salvaged and the components of amniotic fluid (AF) in blood salvaged by one suction device or two devices during CS in patients with placenta previa and/or accrete. METHODS Thirty patients with placenta previa and/or accrete undergoing elective CS in the Women's Hospital of Zhejiang University School of Medicine were recruited for the present study from November 1, 2017 to December 1, 2018. The patients were randomly assigned to one of the two groups according to an Excel-generated random number sheet: Group 1 (n = 15), in which only one suction device was used to aspirate all blood and AF, and Group 2 (n = 15), in which a second suction device was mainly used to aspirate AF before the delivery of the placenta. Three samples of blood per patient (pre-wash, post-wash, and post-filtration) were collected to measure AF components. The salvaged RBC volumes were recorded. Continuous data of pre-wash, post-wash, and post-filtration samples were analyzed by using one-way analysis of variance with Tukey's test for multiple comparisons, or Kruskal-Wallis test with Dunn test for multiple comparisons. Comparisons of continuous data between Group 1 and Group 2 were conducted using Student's t test or Mann-Whitney U test. RESULTS The salvaged RBC volume was significantly higher in Group 1 than that in Group 2 (401.6 +/- 77.2 mL vs. 330.1 +/- 53.3 mL, t = 4.175, P < 0.001). In both groups, squamous cells, lamellar bodies, and fat were significantly reduced by washing (all P<0.001) and squamous cells were further reduced by filtering (P < 0.001). Squamous cells were found in six post-filtration samples (three from each group). Lamellar bodies and fat were completely removed by filtering. Insulin-like growth factor binding protein 1, alpha-fetoprotein, albumin, lactate dehydrogenase, and potassium were significantly reduced post-wash (all P < 0.05), with no further significant reduction after filtration in either group (all P > 0.05). The mean percentage of fetal RBCs post-filtration was (1.8 +/- 0.8)% with a range of 1.0% to 3.5% and (1.9 +/- 0.9)% with a range of 0.7% to 4.0% in Groups 1 and 2, respectively, showing no significant difference between the two groups (U = 188.5, P = 0.651). CONCLUSION Cell salvage performed by one suction device could result in higher volume of salvaged RBCs and can be used safely for CS in patients with placenta previa and/or accrete when massive hemorrhage occurs. TRIAL REGISTRATION NUMBER ChiCTR-INR-17012926, http://www.chictr.org.cn/ Chinese Clinical Trial Registry.
A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial
Health Technology Assessment (Winchester, England). 2018;22((2)):1-88.
BACKGROUND Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking. OBJECTIVES To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use. DESIGN Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded. SETTING A total of 26 UK obstetric units. PARTICIPANTS Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated. INTERVENTIONS Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed. MAIN OUTCOME MEASURES Primary - donor blood transfusion. Secondary - units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer-Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes - costs of resources and service provision taking the UK NHS perspective. RESULTS We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at pound8110 per donor blood transfusion avoided. CONCLUSIONS The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective. FUTURE WORK Research into risk of alloimmunisation among women exposed to cell salvage is needed. TRIAL REGISTRATION Current Controlled Trials ISRCTN66118656. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information.
Cell salvage and donor blood transfusion during cesarean section: a pragmatic, multicentre randomised controlled trial (SALVO)
Plos Medicine. 2017;14((12)):e1002471.
BACKGROUND Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. METHODS AND FINDINGS We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p = 0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, adjusted OR 5.63, 95% CI 1.43 to 22.14, p = 0.013). We are unable to comment on long-term antibody sensitisation effects. CONCLUSIONS The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during cesarean section was not statistically significant. TRIAL REGISTRATION This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656.
Effects of autologous blood injection at Zusanli (ST 36) on ovarian function in patients with primary ovarian insufficiency
Zhongguo Zhen Jiu = Chinese Acupuncture & Moxibustion. 2017;37((11)):1169-72.
OBJECTIVE To observe the effects of autologous blood injection and 0.9% NaCl at Zusanli (ST 36) on ovarian function in patients with primary ovarian insufficiency. METHODS Sixty patients with primary ovarian insufficiency were randomly divided into an observation group and a control group, 30 cases in each one. The patients in the observation group were treated with injection of autologous blood at Zusanli (ST 36); the patients in the control group were treated with 0.9% NaCl with identical volume at Zusanli (ST 36). Both the treatments were given once a week for 3 months. The ovarian function, including follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) were tested before treatment, 1 month, 2 months and 3 months after first acupoint injection; the endometrial thickness before and after treatment and clinical efficacy were compared in the two groups. RESULTS Compared before treatment, FSH was lowered in the observation group after 1-month treatment (P<0.05), while FSH and LH were lowered and E2 was increased after 2-month treatment and 3-month treatment (all P<0.05). Compared with 1-month treatment, FSH and LH were lowered and E2 was increased in the observation group after 2-month treatment and 3-month treatment (all P<0.05). Compared with 2-month treatment, FSH was lowered and E2 was increased in the observation group after 3-month treatment (both P<0.05). The differences of all serum tests before and after treatment were insignificant in the control group (all P>0.05). The FSH after 1-month treatment, and FSH, LH and E2 after 2-month treatment and 3-month treatment in the observation group were significantly different from those in the control group (all P<0.05). The endometrial thickness after treatment in the observation group was higher than that before treatment (P<0.05), while the endometrial thickness after treatment in the control group was similar to that before treatment (P>0.05); the difference of endometrial thickness before and after treatment in the observation group was higher than that in the control group (P<0.05). The clinical effective rate was 83.3% (25/30) in the observation group, which was superior to 46.7% (14/30) in the control group (P<0.05). CONCLUSION The autologous blood injection at Zusanli (ST 36) can significantly improve ovarian function, promote endometrial growth in patients with primary ovarian insufficiency.
Placental blood drainage as a part of active management of third stage of labour after spontaneous vaginal delivery
Journal of Obstetrics and Gynaecology of India. 2016;66((Suppl 1)):242-5.
AIM: The third stage of labour commences after the delivery of the foetus and ends with the delivery of the placenta and its membranes. Postpartum haemorrhage is the most common cause of maternal mortality and accounts for about 25 % of maternal deaths in India. OBJECTIVES The present study was designed to evaluate the effectiveness of placental blood drainage after spontaneous vaginal delivery as part of active management of third stage of labour in decreasing the duration, blood loss, and complications of the third stage, against no drainage of placental blood. METHODOLOGY Two hundred pregnant patients with 37 or more weeks of gestation, with single live foetus in cephalic presentation, who underwent a spontaneous vaginal delivery, were included in the study. The patients were prospectively randomized equally into two groups (100 each in the study and control groups). Placental blood was drained in all the patients in the study group, whereas in the control group the cord blood was not drained. Blood lost in the third stage of labour was measured by collecting in a disposable conical measuring bag, and blood from the episiotomy was mopped, and the mops were discarded separately. RESULTS The baseline statistics in both the group were comparable. The duration of third stage of labour was 210.5 s in the study group and 302.5 s in the control group. The 'p' value was statistically significant (p ≤ 0.0001). The mean blood loss in study group was 227.5 ml and was 313.3 ml in the control group (p ≤ 0.0001). The incidence of postpartum haemorrhage was 1 % in study group and 9 % in control group. The mean drop in Hb % level was 0.6 gm/dl in study group and 1.1 gm/dl in control group. These above differences were both statistically significant. CONCLUSION Placental blood drainage as part of active management of third stage of labour was effective in reducing the duration, the blood loss, and also the incidence of PPH. Placental blood drainage is a simple, safe, and non-invasive method of managing the third stage of labour, which can be practiced in both tertiary care centres as well as rural setup in addition to the routine uterotonics.
Does current evidence support the use of intraoperative cell salvage in reducing the need for blood transfusion in caesarean section?
Current Opinion in Obstetrics & Gynecology. 2014;26((6):):425-430.
PURPOSE OF REVIEW An important cause of maternal morbidity and direct maternal death is obstetric haemorrhage at caesarean section. Concerns regarding allogeneic blood safety, limited blood supplies and rising health costs have collectively generated enthusiasm for the utility of methods intended to reduce the use of allogeneic blood transfusion in cases of haemorrhage at caesarean section. This can be achieved by intraoperative cell salvage (IOCS). The aim of this review is to summarize and examine the evidence for the efficacy of IOCS during caesarean section, in women at risk of haemorrhage, in reducing the need for allogeneic blood transfusion. RECENT FINDINGS The majority of the evidence currently available is from case reports and case series. Although this evidence appears to support the use of IOCS in obstetrics, strong clinical evidence or economic effectiveness from clinical trials are essential to support the routine practice of IOCS in obstetrics. SUMMARY Current evidence is limited to reported case series and two small controlled studies. Overall, IOCS may reduce the need for allogeneic blood transfusions during caesarean section. Future large randomized trials are required to assess effectiveness, cost effectiveness and safety. The results of the current ongoing SALVO (A randomised controlled trial of intra-operative cell salvage during caesarean section in women at risk of haemorrhage) trial will shed light on these aspects.