Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
Conditions
Keywords
acquired von Willebrand disease, severe aortic stenosis, Heye´s syndrome, desmopressin, von Willebrand multimers
Brief summary
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome. We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve replacement surgery will reduce blood loss and transfusion rate. this was a pilot study
Detailed description
Randomized Controlled trial compared with placebo in a double blind fashion. Subjects with severe aortic stenosis (transvalvular gradient \>50 mmHg or valvular area of lass than 1 cm2) scheduled for aortic valve replacement were enrolled. the day of surgery blood samples were taken in order to confirm diagnosis (factor VIII activity and Protein electrophoresis for Von Willebrand´s multimers) and then 0,3 mcg/k of DDAVP or saline equally labeled as study drug were administered en 30 minutes a half hour before incision. Blood loss, postoperative hematocrit and transfusion requirement were measured, plasma sodium was measured as a safety issue.
Interventions
DRUGdesmopressin
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
Sponsors
Ferring Pharmaceuticals
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* severe aortic stenosis defined as mean transvalvular gradient greater or equal to 40 mmHg ot transvalvular area less than 1 cm2 * scheduled for aortic valve replacement surgery
Exclusion criteria
* combined surgery (plus coronary artery bypass graft or other valve replacement/plasty) * Infective Endocarditis * previously known haemostatic disorder * previous treatment with oral anticoagulants or IIb-IIIa inhibitors (we did not exclude those on acetyl-salicylic acid)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood loss | once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration | Blood loss obtained from fluid balance of surgery plus drain output |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hematocrit | the morning after surgery (18-24 hours after drug administration) | hematocrit and hemoglobin in time frame mentioned |
| need of transfusion | 48 hours post administration | transfusion of packaged red cells units until 48 hours after administration of study drug |
Other
| Measure | Time frame | Description |
|---|---|---|
| incidence of hyponatremia | 18-24 hours post administration of study drug | blood sampling for plasma sodium in specified time frame |
| von Willebrand study and protein electrophoresis | the day of surgery, half hour previous to administration of study drug | blood sampling for von Willebrand study: * collagen binding activity * ristocetin factor test * coagulation factor VIII activity * von Willebrand factor antigen * Ristocetin cofactor test/von Willebrand factor antigen ratio and protein electrophoresis of von Willebrand multimers |
Countries
Chile
Outcome results
None listed