IVH in VLBW Preterm Babies – Therapy with Recombinant Activated F VII?

2017 ◽  
Vol 229 (06) ◽  
pp. 335-341 ◽  
Author(s):  
Matthias Knüpfer ◽  
Jenny Ritter ◽  
Ferdinand Pulzer ◽  
Corinna Gebauer ◽  
Nadine Wolf ◽  
...  
Keyword(s):  
Very Low Birth Weight ◽  
Demographic Data ◽  
Fresh Frozen Plasma ◽  
Coagulation Cascade ◽  
Factor Vii ◽  
Control Group ◽  
Posthemorrhagic Hydrocephalus ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Group A

Abstract Backround Intraventricular hemorrhage (IVH) remains a dangerous and frequent complication in very low birth weight (VLBW) infants. Activated factor VII (aFVII) activates the coagulation cascade and is a potential tool for stopping active bleeding, including limiting the extent of an IVH. This retrospective treatment observation compared data for infants with IVH progression treated with fresh frozen plasma (FFP) alone or with a combination of FFP and aFVII. Methods/Intervention All infants were subject to cranial ultrasonography at least twice daily. When an IVH was detected, treatment with FFP (5–20 ml/kg every 4–6 h) was commenced and the parents were informed. If the parents endorsed aFVII treatment and the IVH showed progress, aFVII (30–50 µg/kg body weight 4–6 times within 16–24 h) was given. Otherwise, infants were treated with FFP only. We compared the course of IVH between the aFVII+FFP treated infants and a control group (FFP only). Results 35 patients throughout were included in the analysis (17 control and 18 aFVII group). Demographic data was not different between groups. The progress of IVH was significantly less in the aFVII group (p<0.01). During the hospital stay, 2 of the infants in the aFVII group died compared to 4 in the control group. A posthemorrhagic hydrocephalus developed in 3 aFVII and 6 control infants. All other outcome parameters and follow-up-results 2 years after treatment did not differ significantly. Conclusion These data show that in the case of a progressing IVH, aFVII may be a candidate for limiting its extent. A prospective randomized trial is warranted.

scholarly journals Congenital Deficiency in Factor VII Revealed by Menorrhagia: Case Report

2020 ◽  
pp. 1-5
Author(s):  
Nadia Mebrouk ◽  
Abdelilah Radi ◽  
Mohamed Selouti ◽  
Amal Hassani ◽  
Abdelhakim Ourrai ◽  
...  
Keyword(s):  
Treatment Options ◽  
Specific Treatment ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Activity Measurement ◽  
Recombinant Activated Factor Vii ◽  
Congenital Deficiency ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Fvii Deficiency

Factor VII (FVII) deficiency is the most common among rare inherited autosomal recessive bleeding disorders. It is a multifaceted disease because of the lack of a direct correlation between plasma levels of coagulation FVII and bleeding manifestations. Clinical phenotypes range from asymptomatic condition—even in homozygous subjects—to severe, life-threatening bleedings (e.g., central nervous system and gastrointestinal bleeding). Menorrhagia is a frequent type of bleeding in FVII deficiency, with a prevalence rate of two in three women aged 10 to 50 years and with a peak prevalence in teenagers. When menorrhagia is observed and once the gynecological causes are excluded, it is important to carry out a hemostasis assessment because, if an anomaly is found, specific treatment can be administered and preventive measures taken. Basic diagnostic work-up includes routine assays, prothrombin level, activated partial thromboplastin time and platelet count, followed by FVII coagulant activity measurement for isolated decreased prothrombin level. To confirm the diagnosis, FVII assay should be repeated at least once. Several treatment options are currently available for FVII deficiency: Recombinant activated Factor VII (rFVIIa), plasma-derived Factor VII, fresh frozen plasma and prothrombin complex concentrates. rFVIIa is the most used replacement therapy. Other medical therapies of menorrhagia includes hemostatic agents and hormonal treatments (combined oral contraceptives, levonorgestrel intrauterine devices), in combination or not with rFVIIa. We report the case of a fourteen-and-a-half-year-old girl who presented menorrhagia of great abundance at the age of thirteen, the exploration of which revealed a congenital deficit in FVII.

The Risk of Thrombotic Events in Neonates Treated with Recombinant Factor VIIa.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3193-3193
Author(s):  
John Puetz ◽  
Ginger Darling ◽  
Petr Brabec ◽  
Jan Blatny ◽  
Prasad Mathew
Keyword(s):  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Accurate Determination ◽  
Thrombotic Event ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Control Group ◽  
Fresh Frozen ◽  
Surgical Bleeding ◽  
A Prospective Study

Abstract Background: In recent years, recombinant factor VIIa (rFVIIa) has been used in non-hemophilia bleeding situations (factor VII deficiency, trauma, liver disease, uremia, surgical bleeding, platelet disorders, and intracranial hemorrhage) for achievement of hemostasis. Although, the risk of thrombosis in hemophilia patients with inhibitors receiving rFVIIa is quite low, its use in other clinical situations has been complicated by some reports of thrombotic events. Recently, rFVIIa has been used to treat coagulopathic and/or bleeding neonates with good success. However, the prevalence of thrombotic events in these neonates is completely unknown. This study was initiated to determine the risk of thrombotic events associated with rFVIIa use in neonates. Methods: We reviewed all published literature in neonates receiving rFVIIa. In addition, we reviewed all data submitted to the SeveN Bleep Registry, a database developed by the scientific standardization subcommittee on pediatric and neonatal hemostasis of the International Society on Thrombosis and Haemostasis (ISTH) to record all uses of rFVIIa in pediatric non-hemophilic patients. As the baseline prevalence of thrombosis for bleeding and/or coagulopathic neonates is also unknown, we also reviewed the records of 100 consecutive neonates from a single institution who received fresh frozen plasma (FFP) alone to treat their coagulopathy and/or bleeding. Results: A total of 98 non-hemophilic neonates received rFVIIa. The majority of these neonates received rFVIIa only after failing to achieve hemostasis with standard care (FFP, cryoprecipitate, platelet transfusions). Of those receiving rFVIIa, 7 had a thrombotic event reported. In the control group that received FFP alone, 7 neonates also suffered a thrombotic event. Although the risk of thrombosis in these two groups is similar, neonates receiving rFVIIa tended to have indwelling line related thrombosis, while those receiving FFP tended to have strokes or myocardial insults. Overall the prevalence of thrombotic events in bleeding and/or coagulopathic neonates appears to be 7%, whether or not they received rFVIIa. Conclusions: In this study, the overall prevalence of thrombotic events was similar in the rFVIIa and FFP group. As data for this study was collected in a retrospective manor, and thereby subject to publication and submission bias, a more accurate determination of the prevalence of thrombosis in neonates will require a prospective study.

scholarly journals A Retrospective Analysis of Transfusion Management for Obstetric Hemorrhage in a Japanese Obstetric Center

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Shigetaka Matsunaga ◽  
Hiroyuki Seki ◽  
Yoshihisa Ono ◽  
Hideyoshi Matsumura ◽  
Yoshihiko Murayama ◽  
...  
Keyword(s):  
Blood Product ◽  
Coagulation Factors ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Blood Product Transfusion ◽  
Obstetric Hemorrhage ◽  
Recombinant Activated Factor Vii ◽  
Product Usage ◽  
Activated Factor Vii ◽  
Fresh Frozen

Background. Since cryoprecipitate, fibrinogen concentrate, or recombinant activated factor VII is not approved by public medical insurance in Japan, we retrospectively assessed blood product usage in patients with obstetric hemorrhage at our tertiary obstetric center. Material and Methods. 220 patients with obstetric hemorrhagic disorders who underwent blood product transfusion in our institution during a 5-year period were reviewed for the types and volumes of blood products transfused. Results. There was a significant positive correlation ( 0.001) between the volume of RCC (red blood cell concentrate) transfused and that of FFP (fresh frozen plasma), irrespective of underlying obstetric disorders. The median of FFP to RCC ratio in each patient was 1.3–1.4, when 6 or more units of RCC were transfused. Conclusions. In transfusion for massive obstetric hemorrhage in terms of appropriate supplementation of coagulation factors, the transfusion of RCC : FFP = 1 : 1.3–1.4 may be desirable.

Recombinant activated factor VII for cerebral injury—induced coagulopathy in pediatric patients

2003 ◽  
Vol 98 (3) ◽  
pp. 611-616 ◽  
Author(s):  
John David Morenski ◽  
Joseph D. Tobias ◽  
David F. Jimenez
Keyword(s):  
Injured Patient ◽  
Fresh Frozen Plasma ◽  
Cerebral Injury ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Content Type ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Repeated Doses ◽  
Fine Print

✓ Brain injury remains one of the leading causes of death and disability in children. Appropriate therapy involves aggressive management of intracranial pressure (ICP) and cerebral perfusion pressure, which often requires placement of an intraparenchymal ICP monitor or intraventricular catheter. These potentially life-saving interventions require normal coagulation function; however, several factors may lead to coagulopathy in the head-injured patient. Standard therapies, which often include multiple doses of fresh frozen plasma (FFP), have a number of drawbacks when used in the pediatric population. The use of FFP requires time to type and crossmatch, thaw, and administer. It imposes a significant volume load on a child in whom cerebral edema remains a problem. Success in using recombinant activated factor VII (rFVIIa) in the hemophiliac population suggests an alternative therapy. Three patients suffered severe coagulopathy after cerebral injury. One patient received rFVIIa after repeated doses of FFP had failed to correct the coagulopathy; the other two patients received rFVIIa as the initial therapy. Treatment with rFVIIa consisted of a bolus of 90 µg/kg. Recombinant activated factor VII rapidly corrected the patients' coagulopathies, which allowed placement of intraparenchymal fiberoptic lines and intraventricular catheters to monitor ICP. The patients suffered no complication from the placement of ICP monitoring devices, as demonstrated on computerized tomography scans obtained within 24 hours after placement. Brain injury—induced coagulopathy may lead to significant secondary injury and delays the invasive monitoring necessary for the aggressive management of intracranial hypertension. Fresh frozen plasma takes time to administer, may require repeated doses of significant volume for the pediatric patient, and may ultimately fail. Preliminary data indicated that rFVIIa provides a rapid and successful correction of coagulopathy in the head-injured patient.

Recombinant Activated Factor VII for the Rapid Correction of Coagulopathy in Nonhemophilic Neurosurgical Patients

Neurosurgery ◽  
2003 ◽  
Vol 53 (1) ◽  
pp. 34-39 ◽  
Author(s):  
Paul Park ◽  
Matthew E. Fewel ◽  
Hugh J. Garton ◽  
B. Gregory Thompson ◽  
Julian T. Hoff
Keyword(s):  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Recombinant Activated Factor Vii ◽  
Coagulation Parameters ◽  
Activated Factor Vii ◽  
Optimal Dosing ◽  
Neurosurgical Patients ◽  
Fresh Frozen ◽  
Dilutional Coagulopathy ◽  
Neurosurgical Intervention

Abstract OBJECTIVE Coagulopathy is a significant contraindication for neurosurgery. Unfortunately, many coagulopathic patients require urgent neurosurgical intervention. Standard use of blood products, including fresh-frozen plasma or prothrombin complexes, to correct the coagulopathy often leads to significant delays in treatment. Recombinant activated factor VII (rFVIIa) is a medication originally designed to treat bleeding in hemophiliacs but also seems to correct a wide variety of coagulopathies rapidly and safely in nonhemophilic patients. METHODS The medical records of nine patients with coagulopathy requiring urgent neurosurgical intervention were reviewed retrospectively. Each patient was given a dose ranging from 40 to 90 μg/kg of rFVIIa before undergoing surgery. Pre-rFVIIa coagulation and post-rFVIIa coagulation parameters were obtained. Once correction of the coagulopathy was verified, each patient underwent the appropriate neurosurgical procedure. RESULTS The average age of the patients was 40.9 years; six were women. The causes of the coagulopathy included anticoagulant medication, liver dysfunction, and dilutional coagulopathy after traumatic hemorrhage. Neurosurgical indications included intraparenchymal/intraventricular hemorrhage, hydrocephalus, diffuse cerebral edema, and epidural hematoma. Post-rFVIIa coagulation parameters obtained as early as 20 minutes after infusion of the medication showed normalization of values. There were no procedural or operative complications and no postoperative hemorrhagic complications. No associated thromboembolic or other complications with the use of rFVIIa were observed. CONCLUSION The use of rFVIIa for the urgent surgical treatment of coagulopathic patients is quite promising. Further studies, including randomized, prospective trials using rFVIIa to address issues such as optimal dosing, efficacy, surgical indications, cost-effectiveness, morbidity, and mortality are needed.

Clinical Usefulness of Recombinant Activated Factor VII in Patients with Liver Failure Undergoing Invasive Procedures

2011 ◽  
Vol 45 (11) ◽  
pp. 1433-1438 ◽  
Author(s):  
Jill C Krisl ◽  
Holly E Meadows ◽  
Charles S Greenberg ◽  
Joseph E Mazur
Keyword(s):  
Liver Failure ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Bleeding Complications ◽  
Invasive Procedures ◽  
Recombinant Activated Factor Vii ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Dose Dependent ◽  
Frozen Plasma

Objective: To evaluate the use of recombinant activated factor VII (rFVIIa) in patients with liver failure undergoing invasive procedures. Methods: An OVID/MEDUNE and PubMed search (1997-June 2011) was performed to identify literature on the use of rFVIIa to reduce bleeding risk in patients with liver failure undergoing invasive procedures. Study Selection and Data Extraction: English-language data evaluating the efficacy of rFVIIa to reverse coagulopathies prior to invasive procedures in patients with liver disease were included. Data Synthesis: Following administration of rFVIIa, prothrombin time (PT) and international normalized ratio (INR) response is within 30 minutes. Doses ranging from 20 to 120 μg/kg have been studied, with a reduction in PT seen in a dose-dependent manner. One study in patients with no bleeding administered 5, 20, and 80 μg/kg sequentially during a 24-day period. All doses provided reversal of prolonged PT within 10 minutes, and the duration was dose-dependent. In a study of 15 patients with fulminant liver failure, requiring intracranial pressure monitor placement, a rFVIIa dose of 40 μg/kg was compared to fresh frozen plasma. In patients who received rFVIIa, the PT and INR normalized, compared to none of the patients in the fresh frozen plasma group. Conclusions: Retrospective and prospective data demonstrate that rFVIIa effectively reverses elevated PT and INR, reducing the risk of bleeding and safely facilitating invasive procedures. Based on available data, a dose of 20-40 μg/kg 30 minutes prior to an invasive procedure should be considered in patients with acute or chronic liver failure at risk for bleeding complications. A major limitation of rFVIIa use is the high cost of therapy. A prospective, randomized trial could help determine the appropriate dose of rFVIIa, timing of dose in relationship to procedure, and usefulness of subsequent doses.

Analysis of the venous thromboembolic risk associated with severe postpartum haemorrhage in the NOHA First cohort

2008 ◽  
Vol 100 (05) ◽  
pp. 773-779 ◽  
Author(s):  
Céline Chauleur ◽  
Eva Cochery-Nouvellon ◽  
Eric Mercier ◽  
Guy Aya ◽  
Pierre Marès ◽  
...  
Keyword(s):  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Adjusted Relative Risk ◽  
Thrombotic Risk ◽  
Vein Thrombosis ◽  
Therapeutic Trials ◽  
Activated Factor Vii ◽  
Superficial Vein Thrombosis ◽  
Fresh Frozen ◽  
Frozen Plasma

SummarySevere postpartum haemorrhages (PPH) are responsible for maternal morbidity/mortality. Their complex management sometimes requires haemostatic supplementation, and therapeutic trials on fibrinogen or activated factor VII, which may add to the thrombotic risk, are currently being considered. Furthermore, there is a risk of venous thromboembolism (VTE) during the postpartum period, hence we studied the relationship between severe PPH and VTE in women during their first pregnancy. Among the 32,463 women enrolled between January 1, 1999 and February 1, 2004 in the NOHA First cohort, 317 developed severe PPH, 11 postpartum VTE and 60 had postpartum superficial vein thrombosis (SVT). In the women with severe PPH, whilst there were no episodes of VTE, there were three episodes of SVT, which occurred 6 weeks postpartum. All of the women with severe PPH received packed red blood cell (RBC) units, 29 (9.1%) platelets units, 51 (16.1%) fresh frozen plasma and 29 (9.1%) fibrinogen concentrates. Three patients with both severe PPH and SVT received only packed RBC. Severe PPH or packed RBC unit transfusion were associated with postpartum SVT (adjusted relative risk: 5.3 (1.6–17) and 4.7 (1.5–15) respectively), independent of caesarean section delivery and low-molecular- weight heparin (LMWH) use in the postpartum, but were not independent indicators of one another. This the VTE and SVT risks associated with severe PPH are low (<1% and <2%, respectively).Severe PPH increases the risk of postpartum SVT, but transfusion with platelet units and plasma supplementation using fresh frozen plasma or fibrinogen concentrates do not markedly modulate the risk of venous thrombosis.

A Comparison of Prothrombin Complex Concentrate and Recombinant Activated Factor VII for the Management of Bleeding With Cardiac Surgery

2021 ◽  
pp. 088506662098444
Author(s):  
Alyson Katz ◽  
Tania Ahuja ◽  
Serena Arnouk ◽  
Tyler C. Lewis ◽  
Kassandra Marsh ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Prothrombin Complex Concentrate ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Dose Requirement ◽  
Recombinant Activated Factor Vii ◽  
Packed Red Blood Cells ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Chest Tube Output

Bleeding following cardiac surgery that warrants transfusion of blood products is associated with significant complications, including increased mortality at 1 year following surgery. Factor concentrates, such as prothrombin complex concentrate (PCC), or recombinant activated factor VII (rFVIIa) have been used off-label for bleeding in cardiac surgery that is refractory to conventional therapy. The objective of this retrospective study is to assess the hemostatic effectiveness of 4-factor PCC or rFVIIa for bleeding after a broad range of cardiac surgeries. Patients were included if they were at least 18 years of age and had undergone cardiac surgery with bleeding requiring intervention with 4-factor PCC or rFVIIa. There were no differences observed in the number of packed red blood cells (4-factor PCC: 2 units vs. rFVIIa: 2 units), fresh frozen plasma (0 units vs. 1 unit) or platelet (2 units vs. 2 units) transfusions following the administration of 4-factor PCC or rFVIIa. The patients in the rFVIIa group, required more cryoprecipitate than those in the 4-factor PCC group (4-factor PCC: 2 units (range 0-6) vs. rFVIIa: 2 units (range 0-8), p = 0.03). There were no differences in secondary outcomes of chest tube output at 2, 6, 12 and 24 hours, nor was there a difference in reexploration rates or the median length of stay in the intensive care unit. Thromboembolic complications at 30 days were similar between the two groups (4-factor PCC: 13% vs. rFVIIa 26%, p = 0.08). The total median dose requirement for 4-factor PCC was 1000 units (15 units/kg) and 2 mg (20 mcg/kg) for rFVIIa. The results demonstrate feasibility of utilizing the minimum amount of drug in order to achieve a desired effect. Both 4-factor PCC and rFVIIa appear to be safe and effective options for the management of bleeding associated with cardiac surgery.

Application of recombinant activated factor VII during surgery for a giant skull base hemangiopericytoma to achieve safe hemostasis

2002 ◽  
Vol 96 (5) ◽  
pp. 946-948 ◽  
Author(s):  
Rüdiger Gerlach ◽  
Gerhard Marquardt ◽  
Heimo Wissing ◽  
Inge Scharrer ◽  
Andreas Raabe ◽  
...  
Keyword(s):  
Skull Base ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Neurosurgical Procedures ◽  
Recombinant Activated Factor Vii ◽  
Content Type ◽  
Activated Factor Vii ◽  
Fresh Frozen ◽  
Severe Difficulty ◽  
Tumor Remnant

✓ The authors report on a 64-year-old woman with a huge recurrent skull base hemangiopericytoma, in whom they encountered severe difficulty in attaining intraoperative hemostasis. Standard surgical hemostatic methods and the administration of fresh-frozen plasma and prothrombin complex concentrates failed to stop diffuse bleeding from an inoperable tumor remnant. At a critical point during the operation, the intravenous administration of recombinant activated factor VII, combined with mechanical compression, finally led to satisfactory hemostasis. The rationale for using recombinant activated factor VII in situations of uncontrolled bleeding during neurosurgical procedures is discussed, along with the literature in which the use of recombinant activated factor VII as a maneuver of last resort is reported for hemostasis in other surgical fields.

Analysis of Ascites-Challenged Blood in Patients with Liver Cirrhosis Using Rotational Thromboelastometry: How Robust Is the Evidence on Ascites-Attributed Fibrinolysis?

Digestion ◽  
2021 ◽  
pp. 1-6
Author(s):  
Sotiria Bedreli ◽  
Dimitrios Eleftheriadis ◽  
Michael Jahn ◽  
Ali Canbay ◽  
Fuat Saner ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Dilution Effect ◽  
Negative Control Group ◽  
Fresh Frozen Plasma ◽  
Negative Control ◽  
Control Group ◽  
Rotational Thromboelastometry ◽  
Antifibrinolytic Drugs ◽  
Fresh Frozen ◽  
Cirrhotic Patients

Introduction: For over 30 years, ascites has been postulated to facilitate fibrinolysis in patients with liver cirrhosis. In contrast to previous research employing conventional coagulation tests, this study aimed to characterize hemostatic interactions between blood and ascites using the rotational thromboelastometry (ROTEM). Methods: Blood samples – pure or mixed with ascites in a ratio of 1:1 – from cirrhotic patients (n = 10) were subjected to ROTEM analysis. In addition, a negative control group was built with cirrhotic patients (n = 10) whose blood was mixed with physiologic sodium chloride (0.9% NaCl) solution in a ratio of 1:1. Subsequently, ROTEM measurements were subjected to statistical analysis. Results: During ascites challenge, clotting time (CT, measured in seconds) was significantly prolonged in EXTEM (blood: 70.40 ± 20.40 vs. ascites/blood: 109.8 ± 47.7) and APTEM (blood: 66.50 ± 14.55 vs. ascites/blood: 138.7 ± 105.8), likely reflecting a dilution effect. However, CT in INTEM remained unchanged, suggesting a sustained intrinsic pathway function. Maximal clot firmness (measured in millimeters) in FIBTEM decreased significantly (blood: 14.70 ± 9.55 vs. ascites/blood: 6.00 ± 5.66), thus indicating depletion of fibrinogen in ascites. Strikingly, maximum lysis (measured in %) significantly decreased in EXTEM (blood: 9.30 ± 2.79 vs. ascites/blood: 5.50 ± 2.84), APTEM (blood: 8.50 ± 3.10 vs. ascites/blood: 5.60 ± 2.88), and INTEM (blood: 7.50 ± 2.27 vs. ascites/blood: 5.10 ± 3.48). Conclusions: ROTEM provided new evidence that ascites may not primarily induce fibrinolysis in cirrhotic patients. This finding seems to be of significant importance for the clinical management of cirrhotic patients experiencing complications, for example, abdominal hemorrhage after liver biopsy or paracentesis; here, replacement of prothrombin complex concentrates and/or fibrinogen concentrates may prove more beneficial than the use of fresh frozen plasma or antifibrinolytic drugs.

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