Continuous infusion - Study details

A recent study has confirmed that excellent haemostatic efficacy can be achieved with continuous infusion of KOGENATE® Bayer during major surgery.

Study population Objective Study design Treatment protocol Primary outcome Study results

Study population

14 multi-transfused (>150 exposure days) severe haemophilia A patients (FVIII:C ≤1%)aged 12-58 with no history of FVIII inhibitors, were recruited to the study and underwent 15 elective surgical procedures. 19

Surgeries included:

  • nine orthopaedic operations
  • one multiple teeth extraction
  • one maxillary bone graft
  • three open synovectomies
  • one laparoscopic cholecystectomy

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Objective

A single site, open-label study to evaluate the efficacy and safety of continuous infusion of KOGENATE® Bayer in patients with haemophilia A undergoing major surgery. 19

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Study design

To demonstrate the suitability of different concentrations of KOGENATE® Bayer in continuous infusion, concentrations equivalent to the upper and lower vial sizes were used.12 patients received low concentration and three patients received high concentration KOGENATE® Bayer. 19

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Treatment protocol

  • 14 patients undergoing major surgery received bolus KOGENATE® Bayer to achieve ≥ 80% FVIII concentration 30-60 minutes prior to surgery
  • At the same time, continuous infusion was initiated and used to maintain a steady-state concentration of:

    80% until day 3
    40-50% until day 7
    30-40% until day 10

  • Thereafter, patients received either continuous infusion or bolus injections until hospital discharge
  • A minor amount of heparin (final concentration of 5 U/ml)was added to the infusion solution to prevent local thrombophlebitis

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Primary outcome

Primary outcome was general assessment of haemostasis by the investigator.

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Study results

  • In all cases,surgeons described the haemostatic efficacy during surgery as ‘excellent’ (87%, 13 cases) or ‘good’ (13%, 2 cases) 19
  • Haemostatic efficacy during and following surgery was rated as excellent 19
  • In-use stability was demonstrated over 48 hours 22
  • Target FVIII levels were achieved and there were no unexpected drops in FVIII to sub-therapeutic levels 19
  • There were no drug-related treatment-emergent adverse events 19
  • No patient developed de novo inhibitor antibodies to KOGENATE® Bayer 19

Actual plasma concentrations of rFVIII in haemophilia patients undergoing surgery and treated by continuous KOGENATE® Bayer infusions


 

Desired level of FVIII: 80% (corresponds to 0.8 IU/ml)on Days 1 - 3 after surgery; 40 - 50% (corresponds
to 0.4 - 0.5 IU/ml) on Days 4 - 6 after surgery; 30 - 40% (corresponds to 0.3 - 0.4 IU/ml) on Days 7 - 9 after surgery of the clotting activity. Values represent mean ±SD.

* On Day 6,less than 2/3 of the cohort was available to calculate statistics

reference 19

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References

19. Luboshitz J et al. Hemophilia 2006 World Congress, Vancouver, Canada, May 21-25, 2006.
22. KOGENATE® Bayer Summary of Product Characteristics, August 2010

 

Produced by Bayer. This website is intended for HealthCare professionals.
Date of preparation: December 2010 UK.PH.HN.KOG.2010.250.24.4