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1.
Hemoglobin Change after Red Blood Cell Transfusion for Postpartum Anemia: Secondary Analysis of a Randomized, Controlled Trial
Rush M, Srinivas SK, Hamm RF
American journal of perinatology. 2023
Abstract
OBJECTIVE We aimed to describe hemoglobin (Hb) change after transfusion in the nonacute postpartum anemic population in order to provide clinicians with appropriate expectations regarding Hb rise posttransfusion. STUDY DESIGN We performed a secondary analysis of a randomized controlled trial comparing initial transfusion with 1 unit of packed red blood cells (pRBCs) to 2 units pRBCs for postpartum women requiring nonacute transfusion (n = 66). Inclusion criteria were: age 18 years and older, Hb level either <7 g/dL or >7 g/dL with signs or symptoms of anemia, and > 6 hours postpartum without contraindication to transfusion. Hb assessment was performed 4 to 6 hours after initial transfusion. Hb change (ΔHb) was calculated as posttransfusion Hb minus randomization Hb. Our primary goal was to describe mean ΔHb per pRBC transfused at the 4- to 6-hour posttransfusion blood count. We also compared ΔHb per pRBC transfused by number of units transfused, body mass index (BMI), and symptoms (dizziness and/or fatigue) at time of posttransfusion assessment. RESULTS Participants were mean age 29, mean BMI of 27, and over 70% self-identified as black, 12% identified as white, and 9% as Asian race. Mean Hb prior to transfusion was 6.9 ± 0.6 g/dL. Mean ΔHb per pRBC transfused was 0.9 ± 0.4g/dL. There was no difference in ΔHb per pRBC by BMI category (normal weight < 25 kg/m(2): 1.1 ± 0.2 g/dL; overweight 25-29.9 kg/m(2): 0.9 ± 0.5 g/dL; obese ≥ 30 kg/m(2): 0.9 ± 0.5 g/dL; p = 0.12). Finally, there was also no significant difference in ΔHb per pRBC by whether or not symptoms of anemia persisted after initial transfusion (1.0 ± 0.7 vs. 0.9 ± 0.4 g/dL, p = 0.39). CONCLUSION Our data supports the classically accepted rise in Hb after pRBC of approximately 1 g/dL, regardless of BMI category or anemia symptomatology. The study population includes patients at highest risk of postpartum anemia. The results of our study provide important information for clinicians caring for postpartum patients with nonacute anemia. KEY POINTS · Postpartum anemia is a significant public health issue.. · Providers use hemoglobin change to assess response to blood transfusion.. · The established 1 g/dL change in Hb after transfusion is based on historic surgical populations.. · Our data suggests the 1 g/dL Hb change is applicable to postpartum patients..
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2.
Single- versus multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized, controlled trial
Hamm RF, Perelman S, Wang EY, Levine LD, Srinivas SK
Am J Obstet Gynecol. 2020
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Editor's Choice
Abstract
BACKGROUND The American Academy of Blood Banks recommends single-unit red cell transfusion protocols across medicine to reduce transfusion complications and use of a scarce resource. There is minimal data regarding single-unit protocols within obstetrics. OBJECTIVE We aimed to compare a single- vs. multiple-unit transfusion protocol for treatment of hemodynamically stable postpartum anemia. STUDY DESIGN We performed a randomized trial comparing initial transfusion with 1 unit of packed red blood cells [pRBCs] (single-unit protocol) to 2 units of pRBCs (multiple-unit protocol) from 3/2018-7/2019. Postpartum women >6 hours from delivery who required transfusion were approached for consent. Unstable vital signs, hemoglobin(Hb)< 5g/dL, hemoglobinopathy, and cardiomyopathy were enrollment exclusions. Hemoglobin assessment and standardized clinical evaluation were performed 4-6 hours post-transfusion; additional pRBCs were given if indicated. The primary outcome was total units transfused. Secondary outcomes include length of stay, endometritis, wound separation/infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum. Breastfeeding, depression, maternal attachment, and fatigue scores were assessed at 4-9 weeks postpartum. 66 women were required to detect a 20% reduction in units transfused with a single-unit protocol (power=80%; alpha=0.05). RESULTS 66 women were randomized (33/arm). There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb. Mean number of units transfused was lower in the single- compared to the multiple-unit protocol (1.2u vs. 2.1u, p< 0.001). Only 18.2% of women in the single-unit arm required additional pRBCs. At post-transfusion assessment, women in the single-unit arm had lower Hb (7.8g/dL vs. 8.7g/dL, p< 0.001), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes. CONCLUSION In women with hemodynamically stable postpartum anemia, a single-unit protocol avoids a second unit of pRBCs in >80% of women without significant impact on morbidity. Our work supports use of single-unit initial transfusion in this population.
PICO Summary
Population
Haemodynamically stable postpartum women requiring blood transfusion in a single US centre (n= 66).
Intervention
1 unit of packed red blood cells (pRBCs), (single-unit protocol, n= 33).
Comparison
2 units of pRBCs (multiple-unit protocol, n= 33).
Outcome
There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb. Mean number of units transfused was lower in the single- compared to the multiple-unit protocol (1.2u vs. 2.1u). Only 18.2% of women in the single-unit arm required additional pRBCs. At post-transfusion assessment, women in the single-unit arm had lower Hb (7.8g/dL vs. 8.7g/dL), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
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Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial
Liu Y, Li X, Che X, Zhao G, Xu M
BMC pregnancy and childbirth. 2020;20(1):452
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Free full text
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Editor's Choice
Abstract
BACKGROUND The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery. METHODS A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group. RESULTS No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay. CONCLUSION The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. TRIAL REGISTRATION All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.
PICO Summary
Population
Women undergoing caesarean section (n= 116).
Intervention
Intraoperative cell salvage (n= 58).
Comparison
Control group, allogeneic red blood cell infusion when the haemoglobin concentration was < 80 g/L (n= 58).
Outcome
Patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay.
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A Regression Model for Prediction of Cesarean-Associated Blood Transfusion
Albright CM, Spillane TE, Hughes BL, Rouse DJ
American journal of perinatology. 2019
Abstract
OBJECTIVE To develop a model to predict cesarean-associated red blood cell transfusion. STUDY DESIGN Secondary analysis of all cesarean deliveries in the Maternal-Fetal Medicine Units Network Cesarean Registry. Using a split-sample technique, the derivation group was used to identify associated factors and build predictive models, and the validation group was used to estimate classification errors and determine test characteristics. Using factors available at the time of cesarean, we developed a multivariable logistic regression prediction model. RESULTS A total of 59,468 women were split evenly and randomly into the derivation and validation groups. The overall rate of transfusion was 2.7%. The area under the receiver operating characteristic curve for the derivation and validation groups were 0.82 (95% confidence interval [CI]: 0.80-0.84) and 0.84 (95% CI: 0.82-0.85), respectively (p = 0.16). The strongest predictors of transfusion were placenta previa (odds ratio [OR]: 7.06, 95% CI: 5.19-9.61) and eclampsia/Hemolysis Elevated Liver Enzymes Low Platelets syndrome (OR: 5.67, 95% CI: 3.77-8.51). In the validation group, the model had a sensitivity, specificity, positive, and negative predictive values of 55.8, 91.5, 16.2, and 98.6%, respectively. Overall, 90.5% of patients were correctly classified. CONCLUSION A regression model incorporating variables available at the time of cesarean accurately predicts the need for intra- or postoperative transfusion.
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Effect of withholding feeds on transfusion related acute gut injury in preterm infants - a pilot randomized controlled trial
Sahin S, Gozde Kanmaz Kutman H, Bozkurt O, Yavanoglu Atay F, Emre Canpolat F, Uras N, Suna Oguz S, Underwood MA
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2019;:1-161
Abstract
BACKGROUND Several retrospective studies have reported an increase in necrotizing enterocolitis (NEC) during the 48 hours following red blood cell (RBC) transfusion. Whether withholding enteral feeding during transfusion decreases the risk of transfusion-associated acute gut injury (TRAGI) in preterm infants is unclear. STUDY DESIGN AND METHODS In this pilot study, 112 preterm infants with gestational age ≤ 32 weeks and/or birth weight ≤ 1500 grams were randomly assigned to withholding (NPO) or continuance of feeding (FED) during RBC transfusion. Primary outcome measure was development of NEC (stage ≥ 2) within 72 hours of a transfusion and the change in abdominal circumference. RESULTS One hundred fifty-four transfusion episodes (74 NPO and 80 FED) were analyzed. Demographic characteristics were found to be similar in both groups. There was no difference in rates of NEC (0 versus 3.4%; p = 0.49) between the NPO and FED groups. The incidence of feeding intolerance was higher in the FED group however it was statistically insignificant (1.9 versus 6.8%, p = 0.36). Abdominal circumference remained similar in both groups in all three consecutive days following transfusion (p > 0.05). CONCLUSION This pilot study does not support withholding feedings during transfusion but is not adequately powered to test the hypothesis that NPO decreases NEC rates. Adequately powered well designed multicenter trials are still required.
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Fetal MCA Doppler to time intrauterine transfusions in red cell alloimmunisation: a randomised trial
Dodd JM, Andersen C, Dickinson JE, Louise J, Deussen A, Grivell RM, Voto L, Kilby MD, Windrim R, Ryan G
Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology. 2017;51((3):):306-312
Abstract
OBJECTIVES Red cell alloimmunisation affects up to 0.6% of all live births, and can be successfully treated with intrauterine fetal blood transfusion. Fetal middle cerebral artery (MCA) Doppler peak systolic velocity (PSV) is a non-invasive test, to identify fetal anaemia and requiring intrauterine transfusion (IUT). Traditionally, timing of subsequent IUTs has involved estimating a fall in fetal haematocrit of 1% per day, or a fall in fetal haemoglobin of 0.3 g/dL per day. The aim of this pragmatic multi-centre randomised trial was to evaluate whether Doppler MCA-PSV in the fetus that has undergone one IUT for anaemia secondary to red cell alloimmunisation was non-inferior to timing IUT by timing based on predicting the fall in fetal haematocrit or fetal haemoglobin, without compromising infant haemoglobin at birth. METHODS We conducted an international, multi-centre randomised trial. Women with pregnancies complicated by fetal anaemia secondary to red cell alloimmunisation (due to any antibody alone or in combination) as indicated by the need to undergo a single IUT were eligible for inclusion. Women were randomised to the Timing of Transfusion by MCA-PSV Group (ultrasound determination of the fetal MCA-PSV, with a serial upward trend with values >1.5MoM considered indicative of the need for another IUT), or to the Timing of Transfusion by Prediction of the Fall in Fetal Haematocrit (Hct) Group (subsequent IUT's timed according an estimated fall in fetal Hct of 1% per day or fetal haemoglobin of 0.3 g/dL per day, to maintain the fetal haemoglobin between 7-10 g/dL). The primary study outcome was infant haemoglobin measured at birth. The trial was registered on the Australian and New Zealand Clinical Trials Register (ACTRN12608000643370). RESULTS We randomised 71 women (36 to the MCA-PSV Group; and 35 to the Fall in Fetal Hct. Group) from 13 centres in Australia, New Zealand, Canada, United Kingdom, Ireland, Belgium, and Argentina. The median gestational age at randomisation was 30.3 weeks, and the majority of women were Caucasian and non-smokers; 9.9% of women had Kell alloimmunisation, and 14% of fetuses were hydropic at their first IUT. There were no statistically significant differences between the two treatment groups with regards to mean haemoglobin at birth (MCA-PSV Group 103.6 +/- 38.2 g/dL versus Fall in Fetal Hct Group 120.3 +/- 31.4 g/dL; adjusted mean difference -15.6; 95% CI -32.4 to 1.3; p = 0.070)), or the number of IUTs performed after randomisation (MCA-PSV Group 1.75 (+/-1.79) versus Fall in Fetal Hct Group 1.80 (+/-1.32); adjusted relative risk aRR 0.88; 95% confidence interval (CI) 0.61 to 1.26; p = 0.474). There were no statistically significant differences between the two groups in the risk of adverse infant outcomes related to alloimmunisation, or procedure related complications. CONCLUSIONS Both Doppler MCA-PSV measurement and estimating the fall in fetal haematocrit or haemoglobin can be used to time second and subsequent IUTs.
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Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage
Prick BW, Schuit E, Mignini L, Jansen A, van Rhenen DJ, Steegers E, Mol BW, Duvekot JJ, EBM Connect Collaboration
BJOG: An International Journal of Obstetrics & Gynaecology. 2015;122((13)):1789-97.
Abstract
OBJECTIVE To determine clinical predictors of escape red blood cell (RBC) transfusion in postpartum anaemic women, initially managed expectantly, and the additional predictive value of health-related quality of life (HRQoL) measures. DESIGN Secondary analysis of women after postpartum haemorrhage, either randomly allocated to, or opting for expectant management. SETTING Thirty-seven hospitals in the Netherlands. POPULATION A total of 261 randomised and 362 nonrandomised women. METHODS We developed prediction models to assess the need for RBC transfusion: one using clinical variables (model 1), and one extended with scores on the HRQoL-measures Multidimensional Fatigue Inventory (MFI) and EuroQol-5D (model 2). Model performance was assessed by discrimination and calibration. Models were internally validated with bootstrapping techniques to correct for overfitting. MAIN OUTCOME MEASURES Escape RBC transfusion. RESULTS Seventy-five women (12%) received escape RBC transfusion. Independent predictors of escape RBC transfusion (model 1) were primiparity, multiple pregnancy, total blood loss during delivery and haemoglobin concentration postpartum. Maternal age, body mass index, ethnicity, education, medical indication of pregnancy, mode of delivery, preterm delivery, placental removal, perineal laceration, Apgar score and breastfeeding intention had no predictive value. Addition of HRQoL-scores (model 2), significantly improved the model's discriminative ability: c-statistics of model 1 and 2 were 0.65 (95% CI 0.58-0.72) and 0.72 (95% CI 0.65-0.79), respectively. The calibration of both models was good. CONCLUSIONS In postpartum anaemic women, several clinical variables predict the need for escape RBC transfusion. Adding HRQoL-scores improves model performance. After external validation, the extended model may be an important tool for counselling and decision making in clinical practice.Copyright © 2015 Royal College of Obstetricians and Gynaecologists.
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Obstetric bleeding and transfusion
Jansen AJG, Prick BW, Duvekot JJ
Vox Sanguinis. 2015;109((Suppl. 1)):53-54.. Abstract No. 4C-S23-02.
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Cost-effectiveness of red blood cell transfusion vs. non-intervention in women with acute anaemia after postpartum haemorrhage
Prick BW, Duvekot JJ, van der Moer PE, van Gemund N, van derSalm PC, Jansen AJ, van Rhenen DJ, Mol BW, Uyl-de Groot CA
Vox Sanguinis. 2014;107((4)):381-8.
Abstract
BACKGROUND Red blood cell (RBC) transfusion is frequently used to treat women with acute anaemia after postpartum haemorrhage. We aimed to assess the economic consequences of red blood cell transfusion compared to non-intervention in these women. METHODS A trial-based cost-effectiveness analysis was performed alongside the Well-Being of Obstetric patients on Minimal Blood transfusions (WOMB) trial. Women with acute anaemia [Hb 48-79 g/dl (30-49 mm)] after postpartum haemorrhage, without severe anaemic symptoms, were randomly allocated to RBC transfusion or non-intervention. Primary outcome of the trial was physical fatigue (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Total costs per arm were calculated using a hospital perspective with a 6 weeks time horizon. RESULTS Per woman, mean costs in the RBC transfusion arm (n = 258) were 1957 compared to 1708 in the non-intervention arm (n = 261; P = 0024). The 13% difference in costs between study arms predominantly originated from costs of RBC units, as costs of RBC units were six times higher in the RBC transfusion arm. RBC transfusion led to a small improvement in physical fatigue of 058 points per day; thus, the costs to improve the physical fatigue score with one point would be 431. CONCLUSION In women with acute anaemia after postpartum haemorrhage (PPH), RBC transfusion is on average 249 more expensive per woman than non-intervention, with only a small gain in HRQoL after RBC transfusion. Taking both clinical and economic consequences into account, implementation of a non-intervention policy seems justified.Copyright © 2014 International Society of Blood Transfusion.
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Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial
Prick B, Jansen A, Steegers E, Hop W, Essink-Bot M, Uyl-de Groot C, Akerboom B, van Alphen M, Bloemenkamp K, Boers K, et al
BJOG: An International Journal of Obstetrics & Gynaecology. 2014;121((8):):1005-14.
Abstract
OBJECTIVE To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage. DESIGN Randomised non-inferiority trial. SETTING Thirty-seven Dutch university and general hospitals. POPULATION Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities. METHODS Women were allocated to RBC transfusion or non-intervention. MAIN OUTCOME MEASURES Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum. RESULTS In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable. CONCLUSIONS Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified. 2014 Royal College of Obstetricians and Gynaecologists.