An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.

Bio Products Laboratory

Overview

The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Haemophilia A

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate. Exclusion Criteria: \-

Locations (8)

Klinika Haematologii, Akademia Medyczna w Gdansku, ul.

Debinki 7, 80-211 Gdansk, Poland

Klinika Haematologii, Akademia Medyczna w Lublinie, ul.

Dr K Jaczewskiego 8, 20-090, Lublin, Poland

Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.

Szkolna 8/12, 61-833 Poznan, Poland

Outcomes

Primary Outcomes

Incremental Recovery for plasma Factor VIII

Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG

Time frame: 90 minutes after pre-operative bolus dose

Data from ClinicalTrials.gov

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