Status
Unknown
Phase
Phase 4
Enrollment
108
Locations
1
Results
Not posted
Publications
1
Study summary
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.
Interventions
DRUG
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.
DRUG
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.
Timeline
First posted
Nov 17, 2017
Study start
Feb 2015
Primary completion
Nov 2017
Study completion
Nov 2017
Results posted
Not reported
Registry updated
Nov 17, 2017
Outcomes
Change in coagulation parameters
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
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 (%)
Postoperative blood loss
Time frame · 48 hours
Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours
Blood transfusion
Time frame · 30 days
Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU
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
Eligibility
Inclusion Criteria: * Valve cardiac surgery with cardiopulmonary bypass. * Written informed consent Exclusion Criteria: * Reoperative valve surgery * Hematocrit \< 35% * Ventricular dysfunction (EF \< 40%) * Infection * Body mass index \> 35 * Renal impairment (Creatinin \> 2mg/dL) * Antiplatelet administration within 10 days preceding study surgery * Participation in another interventional clinical study within 30 days * Known or suspected hypersensitivity to the desmopressin * Coagulopathy (INR \> 1.5)
Study locations
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil
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