Tranexamic Acid in the Control of Spontaneous Bleeding in Severe Haemophilia

1973 ◽  
Vol 30 (02) ◽  
pp. 272-279 ◽  
Author(s):  
S. G Rainsford ◽  
A. J Jouhar ◽  
Angela Hall
Keyword(s):  
Side Effects ◽  
Tranexamic Acid ◽  
Transfusion Requirement ◽  
Clinical Severity ◽  
Severe Haemophilia ◽  
Double Blind ◽  
Spontaneous Bleeding ◽  
Bleeding Episodes

SummaryA double-blind cross-over study of the prophylactic value of tranexamic acid (“Cyklokapron”), in a dose of 3.0 g per day, against spontaneous bleeding episodes in severe haemophilia was undertaken. Records of bleeding episodes were maintained during therapy in twenty boys with confirmed clinical severity, over two school terms. A significant reduction (p <0.05) in spontaneous bleeding episodes was attained with an associated lessening in the transfusion requirement of therapeutic material, and without obvious side effects. Recommendations are made for further investigations.

scholarly journals Efficacy and safety of the drug Octofactor in prophylactic treatment in patients with severe haemophilia A

2018 ◽  
Vol 5 (3) ◽  
pp. 60-73 ◽  
Author(s):  
T. A. Andreeva ◽  
V. Yu. Zorenko ◽  
I. L. Davydkin ◽  
V. N. Konstantinova ◽  
O. E. Zalepukhina ◽  
...  
Keyword(s):  
Hemophilia A ◽  
Bleeding Episode ◽  
Coagulation Factor ◽  
Preventive Treatment ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Efficacy And Safety ◽  
Spontaneous Bleeding ◽  
Bleeding Episodes ◽  
Blood Coagulation Factor Viii

Relevance.The development of a new recombinant blood coagulation factor VIII preparation is a promising step towards optimizing the treatment of hemophilia A. An introduction of a new medication into clinical practice precedes a clinical trials to evaluate the efficacy and safety.Materials and methods.The efficacy and safety of the domestic recombinant B-domain deleted blood coagulation factor VIII (FVIII) (moroctocog alfa, Octofactor®, JSC “GENERIUM”) were studied in the preventive treatment of 31 patients aged 21 to 52 years with severe haemophilia A. The Octofactor was administered in doses of 40 ± 5 IU/kg 3 times per week at intervals of at least 48 hours for 21 ± 1 weeks.Results.The efficacy of therapy was evaluated in 30 patients, since 1 patient refused to participate in the trial after the first injection of the study medication. There were registered 43 episodes of bleeding among 11 patients in the course of the preventive treatment with Octofactor. The average number of bleeding episodes was 1.4 ± 2.58. There were 43 bleeding episodes, 9 (20.9 %) of them were posttraumatic, 34 (79.1 %) of them were spontaneous. The average number of the spontaneous bleeding episodes (a major criterion of the efficacy) was 1.13 ± 2.19, which showed a low incidence of exacerbations of the hemorrhagic syndrome in the course of preventive treatment with Octofactor. Among all registered bleeding episodes there were 6 (14 %) mild episodes, 37 (86 %) moderate episodes. Among all spontaneous bleedings there were 6 mild episodes (17.6 %), 28 (82.4 %) moderate episodes. All posttraumatic bleedings were moderate. The vast majority (36, or 83.7 %) of bleeding episodes were stopped with administration of the Octofactor. The average number of administrations of the Octofactor for arresting 1 bleeding episode was 1.2 ± 0.56, for 1 spontaneous bleeding episode – 1.2 ± 0.59. On average, it was required to administer 3534.9 ± 2329.02 IU of the Octofactor to stop 1 episode of bleeding. In the vast majority of patients with severe hemophilia A (83.3–86.7 %),  the remaining activity FVIII was 1 % or more after the administration of the Octofactor in 48 hours. The total amount of the Octofactor, introduced for the prevention of bleeding, was 6,107,000 IU, to stop bleeding – 152,000 IU. The safety of therapy was evaluated in 31 patients. There were recorded 25 adverse events (AE) in 17 patients. Among them the laboratory ones prevailed in 23 (92 %) cases, which is not associated with the use of the trial medication. There were noted nausea and an unpleasant aftertaste in the mouth in 1 patient during the first administration of the Octofactor, and therefore he refused to continue to participate in the trial. Causality 2 AE with the study drug was regarded as definite. Such AE are expected and described in the instructions to the preparation. All AE were not serious and mild and resolved without outcomes. There were no presented thromboembolic events and immunogenic reactions.Conclusions.The obtained data testify to the efficacy and safety of the Octofactor both for preventive measures and for stopping bleeding in adult patients with severe hemophilia A.

A Double Blind Study of the Effect of Tranexamic Acid in Essential Menorrhagia

1968 ◽  
Vol 20 (03/04) ◽  
pp. 583-587 ◽  
Author(s):  
J Vermylen ◽  
M. L Verhaegen-Declercq ◽  
M Verstraete ◽  
F Fierens
Keyword(s):  
Side Effects ◽  
Oral Administration ◽  
Tranexamic Acid ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind

SummaryOral administration of tranexamic acid, in a dosage of 3 g daily from the first day of menstruation onwards, significantly decreases menstrual haemoglobin loss in women with so-called essential menorrhagia.The frequency of side-effects reported did not differ between “active” and “placebo” periods.

Clinical Observations and their Relationship to Laboratory Findings in the Haemophilias

1975 ◽  
Vol 34 (03) ◽  
pp. 734-739 ◽  
Author(s):  
S. G Rainsford ◽  
Angela Hall
Keyword(s):  
Factor Viii ◽  
Clinical Severity ◽  
Adolescent Boys ◽  
Spontaneous Bleeding ◽  
Laboratory Findings ◽  
Von Willebrand's Disease ◽  
Von Willebrand’S Disease ◽  
Clinical Observations ◽  
Laboratory Results ◽  
Bleeding Episodes

SummaryContinuous observations in school terms have been made on the frequency of spontaneous bleeding episodes in a group of adolescent boys suffering from haemophilia (39 cases), Christmas disease (9 cases), and von Willebrand’s disease (2 cases). The observations suggest that in haemophilia other factors, besides the deficient factor VIII, affect the bleeding frequency. In the two boys with von Willebrand’s disease, the lower level of factor VIII was associated with the milder symptoms; whereas in boys with Christmas disease clinical severity and laboratory results seemed to be correlated.

Efficacy of tranexamic acid on side effects of rhinoplasty: A randomized double-blind study

2017 ◽  
Vol 45 (6) ◽  
pp. 897-902 ◽  
Author(s):  
Mohammad Ali Ghavimi ◽  
Koroush Taheri Talesh ◽  
Arezoo Ghoreishizadeh ◽  
Mir Amir Chavoshzadeh ◽  
Ali Zarandi
Keyword(s):  
Side Effects ◽  
Tranexamic Acid ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind

scholarly journals Comparison of the Effectiveness 3% Tranexamic Acid Cream Versus 4% Hydroquinone Cream for Treatment of Epidermal Type Melasma

2021 ◽  
Vol 5 (2) ◽  
pp. 297-304
Author(s):  
Hartika Ketty Marpaung ◽  
Theresia L. Toruan ◽  
Yuli Kurniawati
Keyword(s):  
Side Effects ◽  
Tranexamic Acid ◽  
Gold Standard ◽  
Treatment Duration ◽  
Alternative Therapy ◽  
Severity Index ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Treatment Methods ◽  
Melanin Index

A B S T R A C TBackground: Melasma is an acquired hypermelanosis in areas that are exposed tosun. especially in face. Severity of melasma is measured using modified MelasmaArea Severity Index (mMASI) and Melanin Index (MI). Hydroquinone (HQ) is aneffective drug and also a gold standard in terms of melasma treatment. However. thedrawback of hydroquinone is the treatment duration which is quite long. theoccurence of side effects. and also recurrence potential. Several recent studies showsthat one of the anti-pigmentation agent options. the tranexamic acid (TA). is able toprevent melanocyte activation. The results of various studies found that the use ofTA showed a significant improvement in MASI scores. Objective: To compare theeffectivity of 3% TA cream with 4% HQ cream as an alternative therapy in epidermaltype melasma treatment. Methods: A double-blind. matched. randomized clinicaltrial was conducted during July 2019 until August 2019 at Dr. Mohammad HoesinGeneral Hospital Palembang. Subjects were divided into two groups. The first group.consists of 30 participants. get 3% TA cream; and the second group. consists of 30participants. get 4% HQ cream. Subjects who fulfilled the inclusion criteria wasincluded through a simple randomization. Study subjects wer given random creampot (with label A or B on it) according to the result of simple randomization. Finally.every subjects’ melasma severity was measured using mMASI and mexameter ® .Results: There were differences in terms of baseline. 4 th weeks and 8 th weeks aftertreatment mMASI scores in 3% TA and 4% HQ group. At 8 th week. the mMASI scorethe 3% TA group was lower than 4% HQ group. There was no differences in baseline.4 th weeks and 8 th after treatment MI between the two groups. Melanin index for 3%TA group was lower than 4% HQ group. Conclusion: Three-percent TA cream and4% HQ cream is effective in decreasing mMASI score and MI in epidermal typemelasma. There were differences in terms of the mMASI score during the 8th weekafter treatment between 3% TA and 4% HQ group.

scholarly journals Comparison of the Effectiveness 3% Tranexamic Acid Cream Versus 4% Hydroquinone Cream for Treatment of Epidermal Type Melasma

2021 ◽  
Vol 5 (3) ◽  
pp. 340-347
Author(s):  
Hartika Ketty Marpaung ◽  
Theresia L. Toruan ◽  
Yuli Kurniawati ◽  
Theodorus
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Tranexamic Acid ◽  
Gold Standard ◽  
Treatment Duration ◽  
Alternative Therapy ◽  
Severity Index ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Melanin Index

Background: Melasma is an acquired hypermelanosis in areas that are exposed to sun. especially in face. Severity of melasma is measured using modified Melasma Area Severity Index (mMASI) and Melanin Index (MI). Hydroquinone (HQ) is an effective drug and also a gold standard in terms of melasma treatment. However. thedrawback of hydroquinone is the treatment duration which is quite long. the occurence of side effects. and also recurrence potential. Several recent studies shows that one of the anti-pigmentation agent options. the tranexamic acid (TA). is able to prevent melanocyte activation. The results of various studies found that the use of TA showed a significant improvement in MASI scores. Objective: To compare the effectivity of 3% TA cream with 4% HQ cream as an alternative therapy in epidermal type melasma treatment. Methods: A double-blind. matched. randomized clinical trial was conducted during July 2019 until August 2019 at Dr. Mohammad Hoesin General Hospital Palembang. Subjects were divided into two groups. The first group. consists of 30 participants. get 3% TA cream; and the second group. consists of 30 participants. get 4% HQ cream. Subjects who fulfilled the inclusion criteria was included through a simple randomization. Study subjects wer given random cream pot (with label A or B on it) according to the result of simple randomization. Finally. every subjects’ melasma severity was measured using mMASI and mexameter ® . Results: There were differences in terms of baseline. 4 th weeks and 8 th weeks after treatment mMASI scores in 3% TA and 4% HQ group. At 8 th week. the mMASI score the 3% TA group was lower than 4% HQ group. There was no differences in baseline. 4 th weeks and 8 th after treatment MI between the two groups. Melanin index for 3% TA group was lower than 4% HQ group. Conclusion: Three-percent TA cream and 4% HQ cream is effective in decreasing mMASI score and MI in epidermal type melasma. There were differences in terms of the mMASI score during the 8th week after treatment between 3% TA and 4% HQ group.

FLUOXETINE TREATMENT OF CHILDREN AND ADULTS WITH AUTISTIC DISORDER AND MENTAL RETARDATION

PEDIATRICS ◽  
1994 ◽  
Vol 93 (2) ◽  
pp. 283-283
Author(s):  
Edwin H. Cook ◽  
Randall Rowlett ◽  
Catherine Jaselskis ◽  
Bennett L. Leventhal
Keyword(s):  
Mental Retardation ◽  
Side Effects ◽  
Autistic Disorder ◽  
Clinical Severity ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Pharmacological Agents ◽  
Compulsive Disorder ◽  
Fluoxetine Treatment ◽  
Axis I

An open trial of pharmacological treatment with fluoxetine, ranging from 20 mg every other day to 80 mg per day, led to a significant improvement in Clinical Global Impressions ratings of Clinical Severity in 15 of 23 subjects with autistic disorder and 10 of 16 subjects with mental retardation. Six of 23 patients with autistic disorder and 3 of 16 patients with mental retardation had side effects which significantly interfered with function, consisting predominantly of restlessness, hyperactivity, agitation, decreased appetite, or insomnia. Double-blind studies of the efficacy of pharmacological agents that potently inhibit 5-IIT uptake in the treatment of mental retardation coexisting with Axis I psychiatric disorders (especially obsessive-compulsive disorder) and autistic disorder are warranted.

scholarly journals Long-acting recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in children

2016 ◽  
Vol 116 (10) ◽  
pp. 659-668 ◽  
Author(s):  
Hervé Chambost ◽  
Christoph Male ◽  
Thierry Lambert ◽  
Susan Halimeh ◽  
Tatiana Chernova ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Coagulation Factor ◽  
Factor Ix ◽  
Recombinant Fusion Protein ◽  
Severe Haemophilia ◽  
Spontaneous Bleeding ◽  
Haemophilia B ◽  
Coagulation Factor Ix ◽  
Routine Prophylaxis ◽  
Bleeding Episodes

SummaryA global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1–11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any bleeding episodes on-demand. The mean terminal half-life of rIX-FP was 91.4 hours (h), 4.3-fold longer than previous FIX treatment and clearance was 1.11 ml/h/kg, 6.4-fold slower than previous FIX treatment. The median (Q1, Q3) annualised spontaneous bleeding rate was 0.00 (0.00, 0.91) and was similar between the <6 years and ≥6 years age groups, with a weekly median prophylactic dose of 46 IU/kg. In addition, patients maintained a median trough level of 13.4 IU/dl FIX activity on weekly prophylaxis. Overall, 97.2 % of bleeding episodes were successfully treated with one or two injections of rIX-FP (95 % CI: 92 % to 99 %), 88.7 % with one injection, and 96 % of the treatments were rated effective (excellent or good) by the Investigator. No patient developed FIX inhibitors and no safety concerns were identified. These results indicate that rIX-FP is safe and effective for preventing and treating bleeding episodes in children with haemophilia B with weekly prophylaxis. Routine prophylaxis with rIX-FP at treatment intervals of up to 14 days are currently being investigated in children with severe and moderately severe haemophilia B. Clinicaltrials.gov (NCT01662531)

scholarly journals Effect of tranexamic acid on blood loss, coagulation profile, and quality of surgical field in intracranial meningioma resection: A prospective randomized, double-blind, placebo-controlled study

2021 ◽  
Vol 12 ◽  
pp. 272
Author(s):  
Gopala K. Ravi ◽  
Nidhi Panda ◽  
Jasmina Ahluwalia ◽  
Rajeev Chauhan ◽  
Navneet Singla ◽  
...  
Keyword(s):  
Placebo Group ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Transfusion Requirement ◽  
Intracranial Meningioma ◽  
Intraoperative Blood Loss ◽  
Double Blind ◽  
Coagulation Profile ◽  
Surgical Field

Background: Resection of intracranial meningioma has been associated with significant blood loss. Providing a clear surgical field and maintaining hemodynamic stability are the major goals of anesthesia during meningioma surgery. Tranexamic acid has been used to reduce blood loss in various neurosurgical settings with limited evidence in literature. A randomized, double-blind, and placebo-controlled trial was conducted to evaluate the efficacy of tranexamic acid on blood loss, coagulation profile, and quality of surgical field during resection of intracranial meningioma. Methods: Thirty patients aged 18–65 years undergoing elective meningioma resection surgery were given either tranexamic acid or placebo (0.9% saline), tranexamic acid at a loading dose of 20 mg/kg, and infusion of 1 mg/kg/h during surgery. The intraoperative blood loss, coagulation profile, and the surgical field using Likert scale were assessed. Results: The patients in tranexamic group had significantly decreased intraoperative blood loss compared to the placebo group (616.42 ± 393.42 ml vs. 1150.02 ± 416.1 ml) (P = 0.02). The quality of the surgical field was better in the tranexamic group (median score 4 vs. 2 on Likert Scale) (P < 0.001). Patients in tranexamic group had an improved coagulation profile and decreased blood transfusion requirement (p=0.016). The blood collected in closed suction drain in 24 h postsurgery was less in the tranexamic acid group compared to placebo group (84.7 ± 50.4 ml vs. 127.6 ± 62.2 ml) (P = 0.047). Conclusion: Tranexamic acid bolus followed by infusion reduces perioperative blood loss by 46.43% and blood transfusion requirement with improved surgical field and coagulation profile in patients undergoing intracranial meningioma resection surgery.

scholarly journals Does sickle cell trait reduce the frequency of spontaneous bleeds in severe haemophilia?

2016 ◽  
Vol 3 (2) ◽  
pp. 50-54 ◽  
Author(s):  
Sagir G. Ahmed ◽  
Umma A. Ibrahim ◽  
Modu B. Kagu ◽  
Usman A. Abjah
Keyword(s):  
Sickle Cell ◽  
Sickle Cell Trait ◽  
Globin Gene ◽  
Coagulation Factor ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Spontaneous Bleeding ◽  
Reduced Frequency ◽  
Bleeding Episodes ◽  
Lower Frequencies

Abstract Haemophilia A is an X-linked recessive disorder associated with deficiency of coagulation factor VIII and lifelong bleeding diathesis. Sickle cell trait (SCT) is the heterozygous state for the sickle β-globin gene. The frequency of SCT is up to 30% in Africa, wherein it confers survival advantage by providing resistance against severe malaria. SCT does not cause vaso-occlusive crisis, but is associated with high risk of venous thromboembolism as variously reported in the literature. We consider SCT as a hypercoagulable prothrombotic state and hypothesise that coinheritance of SCT may ameliorate the clinical phenotype of severe haemophilia. We conducted a retrospective analysis of frequencies of spontaneous bleeding among severe haemophiliacs with SCT (Hb AS phenotype) and their counterparts with normal Hb phenotype (Hb AA phenotype) in order to determine the possible ameliorating effect of SCT on spontaneous bleeding rates in severe haemophilia A. If our hypothesis is correct, severe haemophiliacs with SCT will have lower frequencies of spontaneous bleeding than their counterparts with normal Hb phenotype. Our results revealed that severe haemophiliacs with normal Hb phenotype had significantly higher mean annual bleeding episodes per patient in comparison with their counterparts with SCT (45±7 vs 31±5, p=0.033), suggesting that severe haemophiliacs with SCT had lower frequencies of spontaneous bleeding episodes. The result of this study indicates that coinheritance of SCT in patients with severe haemophilia may be associated with reduced frequency of spontaneous bleeding, which may imply better overall prognosis. However, the study has important limitations, which include its retrospective nature and the very low number of subjects. The findings should therefore be validated by a larger and prospective study.

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