Clinical trial: IL-11 in Adults With Von Willebrand Disease Undergoing Surgery (NCT00524225)

Eligibility criteria:
Inclusion Criteria:

          -  Males and females 18 years of age and older

          -  Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
             normal VWF multimers

          -  A past bleeding history

          -  Responsive to DDAVP

          -  Scheduled elective major surgery or major dental surgery at MUH or PUH

          -  Willingness to have blood drawn

        Exclusion Criteria:

          -  Presence of other bleeding disorders, acquired Von Willebrand disease, primary
             thrombocytopenia

          -  Use of immunomodulatory or experimental drugs, or diuretics

          -  Pregnant or lactating women or those unwilling to use contraception during study

          -  Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
             atrial flutter), hypertension, MI, stroke, or thrombosis

          -  Past allergic reaction to Neumega or DDAVP

          -  Surgery within the past 8 weeks

          -  Inability to comply with study protocol requirements

          -  Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

          -  Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing substantial quantities of FVIII and/or VWF within five days of study

          -  Past allergic reaction to Neumega or DDAVP

          -  Surgery within the past 8 weeks

          -  Inability to comply with study protocol requirements

          -  Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

          -  Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing substantial quantities of FVIII and/or VWF within five days of study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment