Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery
- Conditions
- C.Surgical Procedure; CardiacBlood Coagulation Disorders
- Interventions
- Drug: Placebo
- Registration Number
- NCT03343418
- Lead Sponsor
- Instituto do Coracao
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 108
- Valve cardiac surgery with cardiopulmonary bypass.
- Written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%). desmopressin Desmopressin Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
- Primary Outcome Measures
Name Time Method Change in coagulation parameters 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 48 hours Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours
- Secondary Outcome Measures
Name Time Method Length of ICU stay 30 days Clinical complications - renal failure, infection, myocardial ischemia, stroke 30 days Length of hospital stay 30 days Mortality 30 days Duration of Mechanical ventilation 30 days Blood transfusion 30 days Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU
Reoperation for bleeding 30 days Length of vasoactive drugs 30 days
Trial Locations
- Locations (1)
Incor - Heart Institute - University of Sao Paulo
🇧🇷Sao Paulo, Brazil