A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hereditary Factor VIII Deficiency Disease With Inhibitor
Intervention: aPCC, aPCC + TXA (Drug); rFVIIa, rFVIIa + TXA (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s): PÅL A Holme, MD PhD, Principal Investigator, Affiliation: Oslo University Hospital
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clot stability and thrombin generation capacity following treatment with bypassing agents with and without tranexamic acid.
Secondary outcome: DIC or thrombosis events associated with different treatment regimens.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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.
Locations and Contacts
Oslo University Hospital, Oslo 0424, Norway
Additional Information
Starting date: October 2011
Last updated: February 28, 2013
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