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

NCT ID: NCT03343418

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-11-30

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.

Conditions

C.Surgical Procedure; Cardiac; Blood Coagulation Disorders

Keywords

Bleeding; Valve Cardiac Surgery; Desmopressin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

desmopressin

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

Group Type: ACTIVE_COMPARATOR

Desmopressin

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Desmopressin

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Filomena R B G Galas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Incor - Heart Institute - University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

References

Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.

Reference Type: BACKGROUND

PMID: 24951020 (View on PubMed)

Other Identifiers

3962.13.087

Identifier Type: -

Identifier Source: org_study_id