Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery

Instituto do Coracao

Status and phase: Unknown; Phase 4

Conditions: C.Surgical Procedure; Cardiac; Blood Coagulation Disorders

Treatments: Drug: Placebo; Drug: Desmopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT03343418

3962.13.087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

desmopressin

Active Comparator group

Description:

Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.

Treatment:

Drug: Desmopressin

Placebo

Placebo Comparator group

Description:

Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).

Treatment:

Drug: Placebo