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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmopressin | Experimental | 0,3 mcg per kilogram of desmopressin in 100 ml of saline, labeled as "study drug" and administered in 30 minutes a half hour before surgical incision |
|
| placebo | Placebo Comparator | 100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desmopressin | Drug | 0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood loss | Blood loss obtained from fluid balance of surgery plus drain output | once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative hematocrit | hematocrit and hemoglobin in time frame mentioned | the morning after surgery (18-24 hours after drug administration) |
| need of transfusion | transfusion of packaged red cells units until 48 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hyponatremia | blood sampling for plasma sodium in specified time frame | 18-24 hours post administration of study drug |
| von Willebrand study and protein electrophoresis | blood sampling for von Willebrand study:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| esperanza carrasco, anesthesiologist | Pontificia Universidad Catolica de Chile | Principal Investigator |
| rodrigo lopez, anesthesiologist | Pontificia Universidad Catolica de Chile | Study Director |
| guillermo lema, profesor titular | Pontificia Universidad Catolica de Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad Católica de Chile | Santiago | Santiago Metropolitan | Chile |
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| 48 hours post administration |
| the day of surgery, half hour previous to administration of study drug |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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