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
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.
Exclusion Criteria:
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
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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Instituto do Coracao