Acquired Von Willebrand Disease Secondary to Severe Aortic StenosisPhase 4NCT01994330
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
A Phase 4 study testing desmopressin in people with Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis and Heye´s Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- What is being tested?
- desmopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteChile
- Study dates
- Jun 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad Católica de Chile
Santiago, Santiago Metropolitan
About this study
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
Read the 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.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Being tested
- desmopressin
- Keywords
- acquired von Willebrand disease, severe aortic stenosis, Heye´s syndrome, desmopressin, von Willebrand multimers
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressinDrug
Also called DDAVP
0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: desmopressin |
| placebo | Placebo comparator | 100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision Receives: Drug: desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Blood loss obtained from fluid balance of surgery plus drain output
Measured: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration
Secondary outcomes (2)
postoperative hematocrit
hematocrit and hemoglobin in time frame mentioned
Measured: 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
Measured: 48 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Von Willebrand Disease Secondary to Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, MPoblete, Pontificia Universidad Catolica de Chile
- Investigators
- esperanza carrasco, anesthesiologist, Principal investigator, Pontificia Universidad Catolica de Chilerodrigo lopez, anesthesiologist, Study director, Pontificia Universidad Catolica de Chileguillermo lema, profesor titular, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994330
- Sponsor's protocol ID
- RVA
- Status last verified
- Apr 2017
- First submitted
- 14 Nov 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
- ClinicalTrials.gov ID
- NCT01994330
- Acronym / sponsor ID
- RVA
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Keywords
- acquired von Willebrand disease, severe aortic stenosis, Heye´s syndrome, desmopressin, von Willebrand multimers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: desmopressin0,3 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 | Drug: desmopressin100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desmopressinAlso: DDAVP0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision | Drug | Desmopressin, placebo |
Primary outcome
blood loss
Time frame: 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
2 secondary outcomes
postoperative hematocrit
Time frame: the morning after surgery (18-24 hours after drug administration)
need of transfusion
Time frame: 48 hours post administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esperanza carrasco, anesthesiologist principal investigator
Pontificia Universidad Catolica de Chile
rodrigo lopez, anesthesiologist study director
Pontificia Universidad Catolica de Chile
guillermo lema, profesor titular study chair
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing desmopressin in people with Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis and Heye´s Syndrome, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.