Clinical trial: DDAVP vs. Exercise in Patients With Mild Hemophilia A (NCT03136003)

Eligibility criteria:
Inclusion Criteria:

          -  Patients ≥13 years of age and ≤21 years of age with Mild Hemophilia A (MHA), with a
             historical baseline FVIII:C level of ≥5% to ≤40% followed at either the Hospital for
             Sick Children or St. Michael's Hospital (Toronto).

          -  Patients ≥13 years of age and ≤21 years of age with genetically confirmed Mild
             Hemophilia A (MHA), with FVIII:C level of ≥5% to ≤50% followed at either the Hospital
             for Sick Children or St. Michael's Hospital (Toronto).

        Exclusion Criteria:

          -  A currently circulating or history of a previous inhibitor ( ≥0.5 BU) within the past
             5 years. As inhibitor development in MHA is rare, it is not expected that any patient
             will be excluded for this reason.

          -  Any FVIII infusion or DDAVP use in the preceding week. This is to avoid an residual
             FVIII still being present in a patient who has taken an extended half-life FVIII.

          -  Co-existence of a congenital bleeding disorder other than MHA (e.g. VWD).

          -  Prior history of coronary artery disease or pulmonary disease, severe arthropathy
             interfering with ability to exercise.

          -  Patients on beta-blockers, anti-platelet agents or regular non-steroidal
             anti-inflammatory medications (e.g. Celebrex).

          -  Patients with an active infectious or inflammatory condition. This includes HIV,
             active hepatitis B or C as reflected in elevated AST, ALT, RNA positivity for
             hepatitis B or C.

          -  Patients who are active (defined as smoking daily) smokers (cigarettes, marijuana).
             This exclusion is put into place as we do not know if daily smoking will impact on the
             hemostatic response to either exercise or DDAVP.

          -  Patients with limited exercise tolerance for any reason.

          -  Patients with a history of a recent bleed (in preceding 2 weeks) in any location, or a
             joint/muscle bleed in the lower limbs in the preceding 4 weeks.

          -  Patients who for medical reasons should not receive DDAVP [those with renal or CNS
             disease (e.g. brain tumor)] or have previously experienced adverse events with DDAVP
             (e.g. hypotensive event; seizure).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 21 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Entailment