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

NCTNCT03343418Other id3962.13.087

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 108 participants (estimated)
Sponsor: Instituto do Coracao · Other gov
Design: Randomized · Triple masking
Countries: 1 country
Brazil
Start: Feb 2015
Primary completion: Nov 2017 (estimated)
Completion: Nov 2017 (estimated)
First posted: 17 Nov 2017
Last update posted: 17 Nov 2017
Conditions: C.Surgical Procedure; Cardiac · Blood Coagulation Disorders

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018

Ph 4
Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery
NCT03343418
Feb 2015 to est. Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DesmopressinDrug
PlaceboDrug

Arms2

Active comparator
desmopressin
Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
Placebo comparator
Placebo
Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in coagulation parameters
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
Registry description
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
Time frame · 48 hours
Registry description
Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours

Secondary outcomes(8)

Blood transfusion
Time frame · 30 days
Registry description
Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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