A Phase 4 interventional study of Desmopressin and Placebo in C.Surgical Procedure; Cardiac and Blood Coagulation Disorders, sponsored by Instituto do Coracao. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Instituto do Coracao · Phase 4, Interventional, and Prevention
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Among 12 studies in Blood Coagulation Disorders with a site in Brazil — 2 open to participants now, 2 under way, none of them phase 3. Blood Coagulation Disorders · Brazil.
Among the 12 studies in Blood Coagulation Disorders with a site in Brazil, this one is the 4th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2015, is one of 2 in phase 4, and was the 5th registered.
147 studies on the registry are indexed under Blood Coagulation Disorders; 15 are open to participants now.
Browse Blood Coagulation Disorders studies →2 of the 12 studies in Blood Coagulation Disorders with a site in Brazil are open now. Recruiting first, the newest first:
Vega Therapeutics, Inc · Sites in Brazil, United States, Australia and 5 more countries
Ages 12–60 · Healthy volunteers
BioMarin Pharmaceutical · Sites in Brazil, United States, Australia and 9 more countries
Ages 18+ · Men only
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 12 Blood Coagulation Disorders studies recruiting now, 8 (67%) set no upper age limit and 3 (25%) stop at 75 or younger; 5 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 2 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2015.
This study's planned enrollment of 108 is above the median of 49 across 78 interventional studies indexed under Blood Coagulation Disorders.
Median enrollment 82 across the 10 interventional studies, 100 across the 2 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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5 of 12 have an industry lead sponsor. The 8 most frequent:
Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Instituto do Coracao has 2 studies filed under Blood Coagulation Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Blood Coagulation Disorders with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.
Patients with important valve disorders may evaluate with coagulopathy induced by mechanical effects (valvular stenosis or valvular insufficiency). Furthermore, frequently is required prophylactic use of antiplatelet drugs due to myocardial remodeling and antiarrhythmic conditions that may be associated. Patients with severe aortic stenosis may also acquired von Willebrand disease type 2A due to proteolysis of vonWillebrand factor. Despite of this, the treatment of valve disorders often requires cardiac surgery with cardiopulmonary bypass. On average 50 to 60% of patients undergoing cardiac surgery receive blood tranfusions. Blood cell transfusion is an independent risk factor for increased morbidity and mortality in critically ill patients. The use of desmopressin seems beneficial only in patients with congenital or acquired platelet dysfunction. In general population, such use is not validated due to inconclusive results of researches.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
Drug: Desmopressin
Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).
Drug: Placebo
Desmopressin is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given desmopressin 0,3 microgram.kg-1. After desmopressin infusion, bleeding treatment will follow the predefined standardized treatment regimen.
0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 100 milliliters (mL) 0.9% saline (SF0,9%). After 0.9% saline infusion, bleeding treatment will follow the predefined standardized treatment regimen.
Change in coagulation parameters
Laboratory variables: Activated partial thromboplastin time \[(aPTT) seconds\], prothrombin time \[(PT) seconds\], haematocrit (%), haemoglobin(g/dl), fibrinogen(mg/dL), D dimer (ng/L), factor VIII(%), Von Willebrand factor(%), ROTEM \[(INTEM, EXTEM, FIBTEM) Clotting Time (CT) and Clot Formation Time (CFT) seconds, alpha angle (α º), Maximum Clot Firmness (MCF) mm \] and platelets aggregation (%)
Time frame: Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration
Postoperative blood loss
Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours
Time frame: 48 hours
Blood transfusion
Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU
Time frame: 30 days
Reoperation for bleeding
Time frame: 30 days
Duration of Mechanical ventilation
Time frame: 30 days
Length of vasoactive drugs
Time frame: 30 days
Length of ICU stay
Time frame: 30 days
Clinical complications - renal failure, infection, myocardial ischemia, stroke
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Mortality
Time frame: 30 days
The record gives a start of Feb 2015, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deamino Arginine Vasopressin
Instituto do Coracao