Results 1 to 5 of 5

Thread: FDA approves Voluven to treat serious blood volume loss following surgery

  1. #1
    Physician
    Join Date
    Apr 2003
    Location
    Tacloban City, Leyte, Philippines
    Posts
    56

    FDA approves Voluven to treat serious blood volume loss following surgery

    I am not sure if somebody has posted this FDA announcement on Voluven. With my very busy schedule in my anesthesiology practice I realized lately that everybody should be aware of this very important alternative to blood transfusion.

    The U.S. Food and Drug Administration today (December 27, 2007, with revisions posted Jan 25, 2008 and March 8, 2008)) approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

    Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.

    Voluven is manufactured from a water-insoluble starch modified to form hydroxyethyl starch. "Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jess L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research .

    Voluven has been widely used for this indication in Europe and Asia-Pacific.
    Angelina A. Gapay, MD

  2. New Feature! NoBlood Answers!

    • ASK questions regarding Transfusion Alternatives and Patient Blood Management.
    • SHARE your facts, opinions and personal experience.
    • DISCOVER the best answers chosen by Healthcare Professionals and the Public.
    • RANK the best answers.

    Click here to see the Best Answers to Top Questions.

  3. #2
    Registered User
    Join Date
    Feb 2009
    Posts
    116
    I'm guessing that using too much of this product,would cause excessive haemodilution, risks due to that exist. There is plasma volume expanders already on the market, what is this product's niche. [I'll try find out myself].

    I heard of haemaccel [gelatine] being used during the second world war

    Data Sheet

    and in the magazine I read it spoke [I think] of this being used on someone with a haemoglobin of 1.8g/dL, would need to check that.


    the link below is interesting about Voluven and is worthwhile reading for medical professionals or other interested persons

    Critical Care | Full text | Volume substitution therapy with HES 130/0.4 (Voluven(R)) versus HES 450/0.7 (hetastarch) during major orthopedic surgery

  4. #3
    Registered User
    Join Date
    Feb 2009
    Posts
    116

    Smile Voluven, looks excellent according to source quoted

    Volume substitution therapy with HES 130/0.4 (Voluven®) versus HES 450/0.7 (hetastarch) during major orthopedic surgery

    S Gandhi1, D Warltier1, R Weiskopf2, F Bepperling3, D Baus3 and C Jungheinrich3
    1Medical College of Wisconsin, Milwaukee, WI, USA
    2University of California, San Francisco, CA, USA
    3Fresenius Kabi, Bad Homburg, Germany

    from 25th International Symposium on Intensive Care and Emergency Medicine
    Brussels, Belgium. 21–25 March 2005
    Critical Care 2005, 9(Suppl 1):P206doi:10.1186/cc3269
    Published:7 March 2005© 2005 BioMed Central Ltd
    Background

    The first-generation hetastarch remains the only hydroxyethyl starch (HES) available for volume substitution in the United States despite its controversial safety profile. The safety and efficacy of a new HES, Voluven®, was assessed in this investigation.
    Patients and methods

    After local IRB approval and signed, written informed consent, 100 adult patients scheduled for major orthopedic surgery were randomly allocated to receive 6% HES 130/0.4 (Voluven®, n = 49) or 6% HES 450/0.7 (hetastarch, n = 51) for intraoperative volume replacement in a double-blind fashion guided by a predefined algorithm that included CVP-guided therapy. HES volume served as the primary efficacy variable. Safety variables were: calculated total red blood cell (RBC) loss, minimum factor VIII activity and vW factor concentration between the end of surgery and 2 hours later, laboratory parameters, and adverse events through POD 28. The treatment groups were compared for equivalence in efficacy and superiority of HES 130/0.4 in safety.
    Results

    Demographic data and other baseline characteristics of the treatment groups were similar. Mean infused HES volumes were equivalent between groups (1615 ± 778 ml for HES 130/0.4 and 1584 ± 958 ml for HES 450/0.7). Primary safety results are presented in Table 1 (mean ± standard deviation; *P < 0.05). Three coagulopathies were reported as serious adverse events in the HES 450/0.7 group (> 3 l HES 450/0.7 administered in all cases). No coagulopathies were reported for HES 130/0.4.
    Table 1.


    Conclusion

    HES 130/0.4 (Voluven®) and HES 450/0.7 (hetastarch) are equally effective volume expanders in major orthopedic surgery. HES 130/0.4, however, demonstrated a more favorable safety profile including preservation of critical coagulation factors and reduced requirement for transfusion of blood products.
    Last edited by scottishone; 03-11-2009 at 05:30 PM. Reason: posted same thing multiple times

  5. #4
    Physician
    Join Date
    Apr 2003
    Location
    Tacloban City, Leyte, Philippines
    Posts
    56
    It's true, too much of any IV fluid will cause hemodilution of coagulation factors and produce bleeding. Even crystalloids (LR, saline) would hemodilute clotting factors and if the hemodilution approaches 60%, bleeding results.

    Voluven, 6% HES 130/0.4, is a tetrastarch, and is a new-generation low-molecular weight hydroxyethylstarch (HES), while hetastarch HES 450/0.7, is the 1st generation high-molecular weight HES. As mentioned in the literature, Voluven is an improvement in the pharmacology of HES. Hetastarch produces bleeding but voluven causes very minimal effect on coagulation which is similar to that of gelatins. The gelatins may also be used as blood loss replacement, however, the risk of allergic reactions (anaphylactoid) is highest with gelatins, next dextrans, then albumin, and least with starches (according to a study by Laxenaire in >19,000 patients.

    A lot of studies (animal & clinical) have looked into the basic and clinical pharmacology of voluven.
    Angelina A. Gapay, MD

  6. #5
    Registered User
    Join Date
    Sep 2007
    Posts
    64

    Talking Hi

    I had no idea it was that complex

    the literature states that voluven has minimal effect on clotting factors [you'd need to verify that for yourself]

    thanks

    Would this be like gelatin but without the anaphylaxis? [it seems so]

    is there restraints on their use [non blood plasma expanders] such as low haemoglobins....I don't know how expensive it is. The source mentioned use of gelatine for someone with a haemoglobin level of 1.8g/dL, does that sound feasible?

Similar Threads

  1. FDA Approves Sealant to Control Bleeding During Surgery
    By Jan B. Wade in forum News and Hot Topics such as Hepatitis C, SARS and AIDS
    Replies: 0
    Last Post: 01-18-2008, 10:26 AM
  2. FDA Approves Sealant to Control Bleeding During Surgery
    By Jan B. Wade in forum Press Releases
    Replies: 0
    Last Post: 01-18-2008, 10:25 AM
  3. Voluven Helps Minimize Surgical Blood Loss
    By dhcatlady in forum Medical Articles and Abstracts
    Replies: 0
    Last Post: 12-29-2007, 05:17 PM
  4. Replies: 0
    Last Post: 12-28-2007, 03:07 PM
  5. Cancer Patients Do Better With Surgeons, Hospitals That Treat Higher Volume
    By Jan B. Wade in forum Medical Articles and Abstracts
    Replies: 0
    Last Post: 01-19-2006, 10:27 AM

Tags for this Thread

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •