Recombinant activated Factor VII as a hemostatic agent in very low birth weight preterms with gastrointestinal hemorrhage and disseminated intravascular coagulation

OBJECTIVE: Acute hemorrhage in preterm infants leads immediately to a life-threatening event because of the small circulating blood volume. The beneficial use of recombinant activated Factor VII (rFVIIa; NovoSeven, NovoNordisk, Gentofte, Denmark) as hemostatic treatment in neonates with hemorrhagic shock has been described. Necrotizing enterocolitis is a challenge in neonatology as the disease represents one of the leading causes of mortality in preterm infants. We report on the use of rFVIIa in very low birth weight (<1500 g), preterms with intestinal hemorrhage, and disseminated intravascular coagulation (DIC). DESIGN: Retrospective analysis of 5 cases. PATIENTS: Five preterm infants 相似文献   

Is the use of rFVIIa safe and effective in bleeding neonates? A retrospective series of 8 cases

BACKGROUND: Recombinant activated factor VII (rFVIIa), originally developed for the treatment of life-threatening bleeding in hemophilic patients with inhibitors to factors VIII or IX, has been increasingly used to control hemorrhage unresponsive to conventional treatment, in the absence of a defined coagulopathy or thrombocytopathy. To date, clinical experience of rFVIIa administration in neonates, especially preterms, is rather limited, because of the lack of controlled studies and based solely on some published case reports and 1 prospective pilot study. The objective of this study was to retrospectively evaluate the clinical outcome of newborns treated with recombinant activated factor VII for intractable bleeding or severe coagulation disturbances, resistant to conventional hemostatic therapy. METHODS: The medical records of 8 neonates treated with rFVIIa (100 micro g/kg) were retrospectively reviewed for the course of hemorrhage and the hemostatic interventions performed before and up to 24 hours after the administration rFVIIa. Coagulation parameters of 3 different time-points were assessed and compared: before administration of any blood product (time-point 1), before administration of the first dose of rFVIIa (time-point 2), and 4 hours after the administration of the last dose of rFVIIa (time-point 3). The safety and tolerability profile of rFVIIa in bleeding neonates was also evaluated. RESULTS: Six preterm and 2 term patients were included in the study. Seven patients presented with refractory bleeding and 1 was diagnosed with severe coagulopathy unresponsive to the conventional treatment. Prompt hemostasis was achieved in half of the patients with their coagulation profile being restored within 4 hours after the administration of the first dose of rFVIIa. Improvement in prothrombin time, activated partial thromboplastin time, and fibrinogen after rFVIIa administration was statistically significant, as compared with that observed after conventional treatment. No major safety issues were observed during the study. All 8 patients survived and had their hemorrhage or coagulopathy controlled within 4 hours after transfusion of the last dose of rFVIIa. CONCLUSIONS: In this study, the hemostatic agent rFVIIa was well-tolerated and behaved in a safe and efficacious manner in all infants treated for life-threatening bleeding and coagulation disorders. Future prospective controlled trials are needed to determine the efficacy, safety, tolerability, and possibly the optimal dose and timing of rFVIIa administration.     

Blood aggregation in duodenal ulcer

Thirty-six children with duodenal ulcer were examined for the coagulation and thrombocytic components of hemostasis. Use was made of the new coagulologic research methods based on administration of the synthetic tri- and tetrapeptides containing a chromoform group. The high sensitivity of the synthetic peptides enables the use of plasma in high dilutions, owing to which the effect of inhibitors is decreased and a small amount of blood is only required, being of paramount importance in carrying out serial tests. In acute ulcer 1/3 of the children show the signs of the DIC syndrome compensated at the expense of the high content of anticoagulants. At the same time 4 patients were discovered to have coagulologic disorders characteristic of Willebrand's disease (3 cases) and thrombasthenia (1 case). The coagulologic alterations should be taken into consideration in treatment administration, since the compensated DIC syndrome untreated by anticoagulant therapy aggravates the course of the ulcerous process and gives rise to hemorrhagic diathesis. Meanwhile in children with hemorrhagic diathesis, peptic ulcer may cause severe, life-threatening hemorrhages.     

Use of recombinant factor VIIa (rFVIIa) to control intraoperative bleeding in pediatric brain tumor patients

Surgical bleeding during the resection of brain tumors in children may be related to tumor vascularity, pathology, and location. Despite improvements in neurosurgical technique, neuroanesthesia, and blood product replacement, bleeding can be life-threatening in these surgeries. We report eight pediatric patients in whom recombinant factor VIIa (rFVIIa) was used to control intraoperative bleeding during surgical resection of pediatric brain tumors. rFVIIa should be considered as a method to control intraoperative bleeding that is unresponsive to conventional interventions. Additional studies are needed to determine optimal patient selection and drug dosing, efficacy and safety.     

Disseminated intravascular coagulation in pediatric patients: clinical and laboratory features and prognostic factors influencing the survival

Although disseminated intravascular coagulation (DIC) has been a well-known disorder for many years, there is lack of sufficient number of clinical trials about incidence, frequency of underlying disorders, and prognosis of DIC in children. The aim of this study was to evaluate the frequency, etiologic factors, and clinical and laboratory findings of DIC and to determine the prognostic factors influencing the mortality in hospitalized pediatric patients. Medical records of 5535 children who were hospitalized were investigated. Sixty-two patients who were diagnosed as acute DIC were enrolled. The frequency of DIC was 1.12%. The underlying etiologic factors were infection in 59 patients (95.2%) and major trauma in 3 patients (4.8%). The frequency of bleeding and thrombosis was 48.8 and 4.8%. Respiratory, cardiovascular, hepatic, renal, neurologic, and gastrointestinal dysfunction was present in 71, 67.7, 35.5, 16.1, 16.1 and 11.3% of patients, respectively. Respiratory and cardiovascular dysfunctions were significantly associated with mortality. Multiorgan dysfunction syndrome (MODS) was present in 85.5% of the patients, and 54.8% of the patients had developed acute respiratory distress syndrome (ARDS). Mortality rate was significantly high in patients with MODS and ARDS. In multivariete logistic regression analysis, only ARDS and cardiovascular dysfunction had predictive and prognostic value on mortality. None of the diagnostic laboratory tests had predictive or prognostic value and the degree of abnormality of these tests did not show any correlation with mortality. In conclusion, DIC is not a rare disorder in hospitalized children, especially in patients with sepsis, and MODS, ARDS, and respiratory and cardiovascular system dysfunctions are poor prognostic factors.     

Use of recombinant factor VIIa for refractory hemorrhage during extracorporeal membrane oxygenation.

OBJECTIVE: To describe the outcome and treatment of two patients with recombinant factor VIIa (rFVIIa) for severe hemorrhage associated with extracorporeal membrane oxygenation (ECMO). DESIGN: Case report. SETTING: A 38-bed pediatric intensive care unit and 20-bed pediatric cardiac intensive care unit at a tertiary care children's hospital. Patient: Two patients with life-threatening hemorrhagic complications associated with ECMO requiring massive transfusion of blood products. INTERVENTIONS: Administration of repeated doses of rFVIIa at 90 microg/kg/dose. MEASUREMENT AND MAIN RESULTS: Patient 1 was an 11-yr-old male with a dilated cardiomyopathy who had undergone an orthotopic heart transplant treated with venoarterial ECMO postoperatively for right ventricular dysfunction. Patient 2 was a 13-yr-old male treated with venoarterial ECMO for cardiopulmonary failure from necrotizing staphylococcal pneumonia. Both patients had severe hemorrhage from the cannulation sites and thoracostomy tubes requiring massive transfusion to maintain intravascular blood volume and replace clotting factors. Both patients were treated with rFVIIa every 2-4 hrs and attained hemostasis. Patient 1 was administered three doses and Patient 2 was administered ten doses. No evidence of abnormal thrombus formation was noted in their respective ECMO circuits. CONCLUSIONS: The efficacy of rFVIIa in reducing intractable bleeding postcardiac surgery and in other coagulopathic states is being investigated. Despite theoretical concerns of thrombosis, these cases illustrate that there may be a role for the cautious use of rFVIIa in treating severe and intractable hemorrhage associated with ECMO.     

Recombinant factor VIIa improves coagulopathy caused by liver failure

OBJECTIVE: Coagulopathy is an important cause of morbidity and mortality in patients with liver failure. The benefit of traditional therapies to correct coagulation is often limited and short-lived. Our aim is to identify indications for rFVIIa use and the outcome of treatment in children with liver failure. METHODS: A retrospective review from July 2000 to December 2001 was performed to identify consecutive patients with acute or chronic liver failure who received rFVIIa. Prothrombin times (PT) before and after therapy were compared by paired t test. RESULTS: Fifteen patients were treated with rFVIIa for coagulopathy caused by liver failure. All were receiving fresh frozen plasma (mean infusion rate, 39.7 mL/kg/day) when rFVIIa therapy was started. The mean PT before rFVIIa was 32.0 +/- 7.0 seconds. One hour after infusion, the PT normalized to 13.7 +/- 2.4 seconds (P < 0.0001) and remained significantly reduced at 6 hours (19.8 +/- 5.3 seconds; P < 0.0001). A sustained improvement was maintained during the subsequent 3 days. Five of seven patients with bleeding complications improved clinically after rFVIIa treatment. Two of the bleeding patients also benefited from improved fluid balance as fresh frozen plasma support was reduced. No thrombotic events were attributed to rFVIIa therapy. CONCLUSIONS: In patients with liver failure, rFVIIa therapy quickly normalizes the PT and maintains improved hemostasis, even when coagulopathy has been refractory to fresh frozen plasma. Therapy subjectively reduces clinical bleeding and can improve fluid balance, without complications.     

Acute arrhythmogenicity of first-dose chemotherapeutic agents in children

BACKGROUND: Chemotherapeutic agents have been reported to cause severe arrhythmias and sudden death in the first 24 hr after administration. In this prospective study, we determined the magnitude of acute arrhythmogenicity of those agents in children. PROCEDURE: Thirty-three patients with diverse malignancies (leukemia n = 16, Wilms tumor n = 3, brain tumor n = 3, lymphoma n = 3, others n = 8) were studied with Holter monitors 24 hr before, during, and in the first 24 hr following the first-dose therapy. RESULTS: Two patients experienced conduction disturbances (phases of 2nd degree sinuatrial and atrioventricular blocks) during a 4-hr period corresponding to a 30 mg/m(2) daunorubicin infusion. Eight patients experienced supraventricular extrasystole (SE), ventricular extrasystole (VE), and/or short salvos of supraventricular (SVT) and/or ventricular tachycardia (VT). Six had leukemia (therapy: daunorubicin + vincristine), one had a lymphoma (therapy: vincristine + cyclophosphamide), and the last one a brain tumor (therapy: carboplatin + procarbazine). Three patients with leukemia had pretreatment arrhythmias (1 VT, 2 SVT). One of them and the five other patients had arrhythmias during and after the first-dose therapy (2 VE, 2 SVT, 1 SVT + VE, 1 VE + SE + SVT). No patient had life-threatening arrhythmias and no prognostic value of those disturbances could be demonstrated. CONCLUSIONS: Conduction disturbances and arrhythmias are common in cancer children at the beginning of the therapy, but no acute or long-term adverse consequences are related to their appearance.     

Acute duodenal ulcer.

A series of 31 infants and children with acute duodenal ulcer verified by endoscopy was studied over an eight year period. Eighteen (58%) of them were under 2 years of age. The most common symptom was upper gastrointestinal bleeding (n = 27, 87%). Twenty nine patients (94%) had a preceding illness characterised by diarrhoea, upper respiratory tract infection, or fever, which was not necessarily treated with antipyretic drugs. Initial endoscopy showed that ulcer lesions were solitary in 14 patients and present on the anterior wall (n = 11), posterior wall (n = 2), or both (n = 1). Multiple ulcers were found in 17 patients, and present in the bulb with (n = 6) or without (n = 11) extension into the second part of duodenum. The most conspicuous finding was the irregularly shaped ulcers seen in eight young children with similar clinical and endoscopic features. Sixteen patients were re-endoscoped one to two weeks after the initial examination; the ulcers had entirely disappeared in 13, and there were only small residual ulcers in three. Thirty patients were treated medically and only one (with uncontrollable haemorrhage) required operation. Most patients were symptom free two to six years after the initial diagnosis. Our results suggest that young children may develop acute duodenal ulcers after viral illnesses whether or not they are treated with drugs, mainly antipyretics. This kind of acute duodenal ulcer usually heals quickly irrespective of the morphology, site, and number of ulcers.     

持续性和慢性免疫性血小板减少症的临床研究

目的探讨持续性免疫性血小板减少症(persistent ITP,pITP)和慢性免疫性血小板减少症(chronic ITP,cITP)患儿临床特征和疗效。方法对2002年12月-2009年12月间于我院诊断和治疗的pITP和cITP患儿103例的临床资料进行回顾性分析。结果 (1)103例患儿中96.1%年龄分布在学龄前期及以后;男女性别比例为1.24∶1。(2)73.8%有诱因,其中上呼吸道感染占89.5%;患儿病原血清学IgM阳性率为45.0%,混合感染率为36.1%。(3)有黏膜出血者占61.2%,失血性贫血者占25.2%,以轻度贫血为主。就诊时血小板计数<25×109/L者占71.9%。黏膜出血组与非黏膜出血组的血小板计数比较差异无显著性;而血小板减少与贫血程度间比较差异亦无显著性(P>0.05)。(4)遵医嘱维持用药治疗者占59.2%,该组患儿黏膜出血的发生率(55.7%)低于维持间断治疗组(69.0%);而维持用药组患儿失血性贫血发生率(8.2%)显著低于间断治疗组(50.0%),差异有极显著性(χ2=23.034,P<0.001)。(5)单用激素组(79.7%)、激素+IVIG(静脉注射用人免疫球蛋白)组(78.6%)治疗有效率高于激素+VCR(长春新碱)组(40.0%);激素+IVIG与激素+VCR组间疗效差异有显著性(χ2=4.441,P=0.035);单用激素组与激素+VCR组间疗效差异有显著性(χ2=9.772,P=0.002)。结论 (1)pITP和cITP患儿主要见于学龄前期及学龄期儿童,性别差异不明显。(2)上呼吸道感染是儿童pITP和cITP发生的主要诱因,病毒感染在ITP病情反复中起着一定的作用。(3)pITP和cITP患儿出血程度较轻,血小板减少以重型、极重型居多;而出血表现、贫血程度与血小板减少间无相关性。(4)维持用药可减轻pITP和cITP患儿出血症状,降低失血性贫血发生率。(5)单用激素组、激素+IVIG组的治疗有效率显著高于激素+VCR组。     

Bleeding and thrombosis in children with acute lymphoblastic leukaemia, treated according to the ALL-BFM-90 protocol.

A multi-center retrospective survey was conducted to evaluate the incidence and types of hemostatic complications occurring in children with acute lymphoblastic leukemia (ALL) during treatment according to the ALL-BFM-90 treatment protocol. All of the BFM-treatment centers (n = 77) were approached and a 95% response rate with information on 1100 patients was obtained. Thrombotic or bleeding episodes occurred in 31 patients (2.8%), 19 of whom had thrombosis and 12 bleeding complications, involving the central nervous system (42%), the subclavian vein (29%), the gastro-intestinal tract, skin, lower extremities or pelvis (29%). Recovery was noted in 28 of 31 patients, while 3 died as a result of hemostatic complications. Bleeding or thrombosis occurred in patients receiving prophylactic substitution with plasma or plasma-derived concentrates (n = 16) as well as in those without substitution (n = 13). The majority of hemostatic complications (90%) occurred during the induction therapy of the treatment protocol, in particular during the period which included simultaneous administration of glucocorticoids and E. coli L-asparaginase. The concurrent administration of E. coli L-asparaginase and glucocorticoids may be an additional risk factor for thromboembolic events during therapy according to the ALL-BFM-90 protocol.     

Control of bleeding associated with hemophagocytic syndrome in children: an audit of the clinical use of recombinant activated factor VII

This paper presents 2 cases of hemophagocytic lymphohistiocytosis (HLH) in whom recombinant factor VIIa (rFVIIa) was used for the management of hemorrhage. Both patients were diagnosed as HLH and were bleeding from the gut, which could not be controlled. Patients received rFVIIa at total doses of between 90 and 180 μg/kg body weight. Hemostatic affect was achieved in both of the patients but lasted only a short time. The response was achieved after 1 h of administration of rFVIIa, lasting for 24 h. The use of rFVIIa was well tolerated. These 2 patients suggest that rFVIIa is a beneficial agent in the management of hemorrhage in patients with HLH, although for a permanent homeostasis the control of primary disease is essential.     

SUCCESSFUL CONTROL OF MASSIVE GASTROINTESTINAL BLEEDING FOLLOWING UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) BY USE OF RECOMBINANT ACTIVATED FACTOR VII (RFVIIA) AND OCTREOTIDE INFUSION

Post hematopoietic stem cell transplantation (HSCT) gastrointestinal (GI) bleeding is a dreaded complication. There are only five other reports (one randomised trial and four case reports) of use of rFVIIa for massive lower GI bleeding post-allogeneic HSCT. In only one publication, two adult patients showed complete response. Eroglu has reported a response rate of 50% to octreotide in gastrointestinal bleeding in patients without portal hypertension. We present a 10 month-old female child, who had three episodes of life threatening lower GI bleeding post unrelated Umbilical Stem Cell Transplant (UCBT) controlled successfully each time by use of rFVIIa and octreotide infusion and review of literature. To our knowledge this is the first and youngest case reported, in which both rFVIIa and octreotide have been used successfully to control life threatening lower GI bleeding post UCBT.     

The use of recombinant coagulation factor VIIa in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass.

OBJECTIVE: To assess the hemostatic efficacy of recombinant coagulation factor VIIa (rFVIIa) in the management of uncontrolled bleeding in postcardiac surgery with cardiopulmonary bypass in children. DESIGN: An open-label study. SETTING: A postoperative intensive care unit. PATIENTS: Eight consecutive pediatric patients with excessive bleeding after cardiac surgery with cardiopulmonary bypass that met the criteria for reexploration and did not respond to optimal transfusions of platelets and fresh frozen plasma. INTERVENTIONS: rFVIIa 30 microg/kg was given as a bolus injection. A higher dose of 60 microg/kg was used if a patient had preoperative coagulopathy, preoperative multiple-organ failure, or indications that required an emergency operation. The same dose was repeated 15 mins after the previous injection if the bleeding had not decreased. If the bleeding had decreased but still exceeded 10 mL/hr for body weight 5 kg, the same dose was repeated 2 hrs after the previous injection. A maximum of four doses could be given before rFVIIa was considered ineffective and a reexploration was needed. MEASUREMENTS AND MAIN RESULTS: Postoperative blood loss was estimated from the volume of chest tube drainage. rFVIIa successfully controlled bleeding and prevented reexploration in all seven patients who received treatment according to the protocol. One patient who received only one dose of rFVIIa required reexploration because a second dose was not available. No adverse events related to rFVIIa were seen. CONCLUSIONS: rFVIIa may be useful in preventing reexploration in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass. Randomized, placebo-controlled studies are needed to confirm the safety and efficacy of rFVIIa in this clinical setting.     

Causes of mortality in children with acute lymphocytic leukemia.

Fifty five deaths between January, 1982 to September, 1989 in children with acute lymphoblastic leukemia (ALL) were evaluated to determine the cause of mortality. Fifty cases died during remission. Infection alone was responsible for death in 26 of 55 (47.3%) cases while hemorrhage was seen in 7 (12.7%) children. Infection and hemorrhage together were responsible in another 13 cases. Gastrointestinal tract and pulmonary system were the major sites of bleeding. Infections either alone or in combination with other factors were responsible for death in 42 of 55 (76.5%) of children. Septicemia (n = 11), gastrointestinal (n = 15) and pulmonary infections (n = 10) and meningitis in 2 cases were the major sites of infections. Pseudomonas and Klebsiella in 6 cases each accounted for 54.5% of isolates.     

Use of recombinant activated factor VII in intractable bleeding during pediatric neurosurgical procedures.

OBJECTIVE: To report the use of recombinant activated factor VII (NovoSeven; Novo Nordisk A/S, Bagsvaerd, Denmark) in children undergoing major neurosurgical procedures and experiencing massive uncontrolled hemorrhagic shock. DESIGN: Retrospective review of patients and analysis of clinical and biological effects of an intravenous administration of recombinant activated factor VII. SETTING: Neurosurgical anesthesia and critical care unit of a pediatric university hospital. PATIENTS/SUBJECTS: Four children, <12-kg body weight, experiencing life-threatening perioperative hemorrhage required conventional treatment (massive red blood cells, fresh frozen plasma, platelet transfusion, and surgical hemostatic maneuvers) that failed to obtain definite hemostasis. INTERVENTIONS: Intravenous administration of recombinant activated factor VII (100 microg/kg). RESULTS: Intravenous administration resulted in a significant decrease in blood loss within minutes (preventing further need of transfusion), normalization of biological hemostasis markers, and improved surgical hemostasis. No side effects of recombinant activated factor VII were noted, and all patients, except one, had a good recovery. CONCLUSIONS: These four patients support the use of recombinant activated factor VII as a useful adjunct to control massive life-threatening bleeding during pediatric neurosurgical procedures when other means failed. However, the data are still limited in children, and more extensive research is needed to define the indications of recombinant activated factor VII in massive surgical hemorrhage in low-weight children.     

Hemostasis and fibrinolysis in acute lymphoblastic leukemia (ALL) in childhood--analysis of life-threatening bleeding

66 children with ALL, who were admitted to the University Children's Hospital at Münster for treatment according to the BFM protocol 79/81, presented initially with the following abnormal hemostatic parameters: Prolongation of bleeding time (89%), thrombocytopenia (83%), pathological prothrombin time (69%), increased FDP (32%, reduced F XIII (33%), abnormal short PTT (34%). There was a significant discrepancy between immunologically and functionally measured fibrinogen, which is only partially explained by the presence of FDP. Patients with T-cell leukemia (n = 11) had significantly higher WBC, longer prothrombin times, and lower fibrinogen levels than patients with Non-T/non-B ALL. The initial coagulation parameters did not discriminate the 6 patients who presented life threatening bleeding episodes. The two patients with high blast count (350 000 and 548 000/mm3) and T-ALL had intracranial bleeding before therapy started; in one of them vascular infiltration of blast cells was demonstrated at autopsy. Two other patients had bacterial infections, which in one case led to local bleeding into the lungs and in the other case to DIC. Two further children presented intracranial bleeding episodes which could be associated with asparaginase therapy. 5 of the 6 patients with life threatening episodes had a platelet count of more than 35 000/mm3.     

小儿肝移植近期并发症防治

目的探讨小儿肝移植术后管理经验以及近期并发症的防治。方法2001年11月至2003年12月行小儿肝移植7人8例次，其中亲体肝移植2例，减体积肝移植3例，劈离式肝移植2例。术后即送至ICU监护并监测重要脏器功能、凝血功能及生化指标，早期用免疫抑制剂和预防性应用抗生素，每日Doppler检查肝脏血流速度和频谱。结果1例术后第5d死于急性肾功能衰竭；其他近期并发症还包括：腹腔内大出血2例、门静脉栓塞1例、肝静脉狭窄1例、右上肺不张5例、成人呼吸窘迫综合征(ARDS)及肺炎2例、消化道出血3例、腹腔感染1例、伤口感染2例、病毒感染3例、肾功能损伤2例、胆道并发症2例、急性排斥反应2例。结论小儿可成功施行肝移植手术，然而，术后并发症的风险却不容忽视。     

儿童急性泛发性发疹性脓疱病的临床分析

目的：了解儿童急性泛发性发疹性脓疱病的发病原因、临床特点及治疗方法。方法：回顾性分析1990年2月至2008年2月该科收治的20例儿童急性泛发性发疹性脓疱病的临床资料。结果：18例患儿发病前有明确的用药史,20例患儿均有发热、全身性红斑、小脓疱。组织病理学检查示表皮内或角层下脓疱形成和真皮浅层水肿。去除可能的发病因素并给予糖皮质激素等治疗后所有患儿均痊愈。结论： 儿童急性泛发性发疹性脓疱病是一种较少见的疾病,多由药物引起,发热和泛发小脓疱是该病的特点,去除诱发因素和及时应用糖皮质激素是治疗的关键。     

Decreasing the Need for Transfusion: Infant Cardiac Surgery Using Hemodilution and Recombinant Factor VIIa

Many strategies, including intraoperative acute normovolemic hemodilution (ANH) and pharmacologic agents, exist to minimize the use of allogeneic blood products in pediatric congenital heart surgery. Recombinant activated factor VIIa (rFVIIa) is a hemostatic agent approved for the treatment of bleeding episodes and prevention of bleeding in surgical interventions in patients with hemophilia A or B with inhibitors, acquired hemophilia, or congenital factor VII deficiency. Off-label use in nonhemophilic patients for uncontrolled hemorrhage is increasing although still under investigation. We present our experience with ANH and rFVIIa in nine patients. All were <16 months of age and underwent complex cardiac surgery with the end point of achieving hemostasis while decreasing or eliminating the need for allogeneic blood products. Clinically, we have observed rapid hemostasis in patients who underwent ANH and then had autologous blood reinfused after cardiopulmonary bypass, along with rFVIIa, without any time delay. The patients required no allogeneic blood products and therefore results suggested the potential utility of this practice. The study group consisted of nine patients <16 months of age who received rFVIIa in the operating room after open-heart surgery. Amount of autologous blood removed preoperatively, blood product use, time from protamine to rFVIIa administration, platelet count, INR, and fibrinogen level were retrospectively obtained. Of the nine patients, the three who underwent the most aggressive hemodilution received rFVIIa most rapidly and required no allogeneic blood products to achieve hemostasis although they had an average lower fibrinogen level on admission to the cardiothoracic intensive care unit. These preliminary data suggest that hemodilution before surgical stimulation and the rapid administration of rFVIIa, along with the reintroduction of autologous blood, may decrease or potentially eliminate the need for allogeneic blood products. Prospective trials are warranted to further explore this technique.