Clinical Trial: Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL's High Purity FACTOR X in the Treatment of Factor X Deficient Subjects Undergoing Surgery

Brief Summary:

To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery.

The secondary efficacy endpoints are as follows:

  1. A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery.
  2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of post-operative bleeding, including location and duration.
  3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.
  4. Assessment of FX:C and FX:Ag levels on each day post-surgery.
  5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to maintain haemostasis.
  6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis.
  7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each post-operative day) to maintain haemostasis.

Detailed Summary: To investigate the safety and efficacy of FACTOR X administered by bolus infusion to prevent bleeding and achieve haemostasis in factor X deficient subjects undergoing surgery.
Sponsor: Bio Products Laboratory

Current Primary Outcome:

  • Clinical Estimation of Volume of Blood Loss During Surgery [ Time Frame: Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X. ]

    As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count.

    The clinical assessment was rated as follows:

    • Blood loss less than expected
    • Blood loss as expected
    • Blood loss more than expected
    • Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery)
  • Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. [ Time Frame: After wound closure ]
    The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than.
  • Requirement for Blood Transfusion [ Time Frame: during and after surgery ]
    Number of blood transfusions required (units

    Original Primary Outcome: The primary efficacy variable is the presence or absence of excessive blood loss during and after surgery. [ Time Frame: After surgery for each subject. ]

    Current Secondary Outcome:

    • Incremental Recovery After Bolus Dose of FACTOR X [ Time Frame: incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus ]

      Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value.

      Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg)

    • Dose Per Infusion (IU/kg) [ Time Frame: before surgery, during the post operative period ]
      weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery


    Original Secondary Outcome: A subjective overall assessment by the investigator of FACTOR X in the control of bleeding due to surgery throughout the whole study. [ Time Frame: This will assessed througout the study until discharge of the patient. ]

    Information By: Bio Products Laboratory

    Dates:
    Date Received: November 10, 2009
    Date Started: March 2011
    Date Completion:
    Last Updated: January 30, 2017
    Last Verified: January 2017