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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01994330 |
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Date of registration:
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14/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
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Scientific title:
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Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01994330 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Chile
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Contacts
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Name:
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guillermo lema, profesor titular |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Name:
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esperanza carrasco, anesthesiologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Name:
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rodrigo lopez, anesthesiologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pontificia Universidad Catolica de Chile |
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Key inclusion & exclusion criteria
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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)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heye´s Syndrome
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Severe Aortic Stenosis
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Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis
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Intervention(s)
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Drug: desmopressin
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Primary Outcome(s)
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blood loss
[Time Frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration]
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Secondary Outcome(s)
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need of transfusion
[Time Frame: 48 hours post administration]
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postoperative hematocrit
[Time Frame: the morning after surgery (18-24 hours after drug administration)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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