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

NCT03343418 | Unknown Phase 4

• 1 other identifier: 3962.13.087
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

C.Surgical Procedure; Cardiac; Blood Coagulation Disorders

Keywords

Bleeding; Valve Cardiac Surgery; Desmopressin

Outcome Measures

Primary Outcomes (2)

• 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 (%)

  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

  48 hours

Secondary Outcomes (8)

• Blood transfusion

  30 days

• Reoperation for bleeding

  30 days

• Duration of Mechanical ventilation

  30 days

• Length of vasoactive drugs

  30 days

• Length of ICU stay

  30 days

Study Arms (2)

desmopressin

ACTIVE COMPARATOR

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

Drug: Desmopressin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Desmopressin 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.

desmopressin

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Valve cardiac surgery with cardiopulmonary bypass.
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24951020 BACKGROUND

MeSH Terms

Conditions

Blood Coagulation Disorders; Hemorrhage

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

BR (1)