Back to resultsA Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor (BPATXAS)
Primary Purpose
Hereditary Factor VIII Deficiency Disease With Inhibitor
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
aPCC, aPCC + TXA
rFVIIa, rFVIIa + TXA
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Factor VIII Deficiency Disease With Inhibitor
Eligibility 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.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
aPCC, aPCC + TXA
rFVIIa, rFVIIa + TXA
Arm Description
aPCC 75IU/kg i.v aPCC 75IU/kg i.v +TXA 20mg/kg
rFVIIa 90 µg/kg i.v rFVIIa 90 µg/kg i.v + TXA 20 mg/kg
Outcomes
Primary Outcome Measures
Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid.
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
DIC or thrombosis events associated with different treatment regimens.
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.
Full Information
NCT ID
NCT01800435
First Posted
February 15, 2013
Last Updated
February 28, 2013
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01800435
Brief Title
A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Acronym
BPATXAS
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Factor VIII Deficiency Disease With Inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aPCC, aPCC + TXA
Arm Type
Active Comparator
Arm Description
aPCC 75IU/kg i.v aPCC 75IU/kg i.v +TXA 20mg/kg
Arm Title
rFVIIa, rFVIIa + TXA
Arm Type
Active Comparator
Arm Description
rFVIIa 90 µg/kg i.v rFVIIa 90 µg/kg i.v + TXA 20 mg/kg
Intervention Type
Drug
Intervention Name(s)
aPCC, aPCC + TXA
Other Intervention Name(s)
Feiba i.v, Feiba i.v + Cyklokapron
Intervention Description
Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o
Intervention Type
Drug
Intervention Name(s)
rFVIIa, rFVIIa + TXA
Other Intervention Name(s)
NovoSeven 90 µg/kg i.v, NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Intervention Description
NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
Primary Outcome Measure Information:
Title
Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
DIC or thrombosis events associated with different treatment regimens.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PÅL A Holme, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
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