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A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor (BPATXAS)

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ClinicalTrials.gov Identifier: NCT01800435
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Pål Andre Holme, Oslo University Hospital

Brief Summary:
Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients with high titer inhibitors. However, management of bleeds in these patients can be challenging due to variation in response and lack of standardized methods to monitor the effect. We hypothesized that significant increase in whole blood clot stability could be achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin generation remains unaffected. In this prospective crossover study the effect of aPCC and rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively. In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was assessed.

Condition or disease Intervention/treatment Phase
Hereditary Factor VIII Deficiency Disease With Inhibitor Drug: aPCC, aPCC + TXA Drug: rFVIIa, rFVIIa + TXA Phase 4

Detailed Description:
Patients receive the first day aPCC (75IU/kg) and aPCC in addition to TXA (20mg/kg orally) the second day. After a 14 days washout period they crosse over using rFVIIa (90 µg/kg) otherwise the same experimental setup. Blood sampling is performed at baseline, 15, 30, 60, 120, 180 and 240 minutes post-treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Blood Clot Stability and Thrombin Generating Capacity Following Treatment With Bypassing Agents (BPA) With and Without and Tranexamic Acid (TXA) in Haemophilia A Patients With inhibitor-an In-vivo Prospective Crossover Study
Study Start Date : October 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Active Comparator: aPCC, aPCC + TXA
aPCC 75IU/kg i.v aPCC 75IU/kg i.v +TXA 20mg/kg
Drug: aPCC, aPCC + TXA
Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o
Other Names:
  • Feiba i.v
  • Feiba i.v + Cyklokapron

Drug: rFVIIa, rFVIIa + TXA
NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Other Names:
  • NovoSeven 90 µg/kg i.v
  • NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg

Active Comparator: rFVIIa, rFVIIa + TXA
rFVIIa 90 µg/kg i.v rFVIIa 90 µg/kg i.v + TXA 20 mg/kg
Drug: aPCC, aPCC + TXA
Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o
Other Names:
  • Feiba i.v
  • Feiba i.v + Cyklokapron

Drug: rFVIIa, rFVIIa + TXA
NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Other Names:
  • NovoSeven 90 µg/kg i.v
  • NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg




Primary Outcome Measures :
  1. Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid. [ Time Frame: 2 years ]
    MCF (maximum clot formation/mm x 100-1), AUC (area under the elasticity curve AUC, mm• 100 s-1) were used as the primary outcome measures for evaluating clot stability and (ETP) the coagulable state.


Secondary Outcome Measures :
  1. DIC or thrombosis events associated with different treatment regimens. [ Time Frame: 2 years ]
    DIC parameters such as aPTT, PT/INR, platelet count, fibrinogen and D-dimer with the scoring system proposed by the International Society of Thrombosis and Haemostasis were used to monitor DIC in addition to common clinical signs associated with DIC were records. Symptoms or clinical signs of thrombosis such as dyspnea, chest pain, legg swelling or discomfort/pain were recorded.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Haemophilia patients with high titer inhibitors or high-responding inhibitors, aged between 18-65 and no history of aspirin or NSAID use within the last 14 days were eligible for the study.

Exclusion Criteria:

  • Patients with renal failure, liver disease, infected with immune deficiency virus (HIV), platelet count <150x109/L, acquired haemophilia, ongoing bleeding, hypersensitivity to TXA or a history of arterial or venous thrombosis were excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800435


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: PÅL A Holme, MD PhD Oslo University Hospital

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Responsible Party: Pål Andre Holme, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01800435     History of Changes
Other Study ID Numbers: EudraCTnr. 2010-022668-11
2010-022668-11 ( EudraCT Number )
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Hemophilia A
Deficiency Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Malnutrition
Nutrition Disorders
Tranexamic Acid
Factor VIII
Anti-inhibitor coagulant complex
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants