Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery

NCT ID: NCT04260204

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-02

Study Completion Date

2020-01-25

Brief Summary

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The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

Detailed Description

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This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were included in the study if they had left to right shunt due to volume or pressure overload
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
double-blind masking

Study Groups

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Retrograde priming

retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

Group Type ACTIVE_COMPARATOR

Pediatric cardiac surgery

Intervention Type PROCEDURE

conventional priming

conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

Group Type ACTIVE_COMPARATOR

Pediatric cardiac surgery

Intervention Type PROCEDURE

Interventions

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Pediatric cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* children complained of congenital heart disease with left to right shunt pressure or volume load

Exclusion Criteria

* cyanotic heart disease
Minimum Eligible Age

12 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hamdy Singab

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamdy Singab, PhD

Role: PRINCIPAL_INVESTIGATOR

Ain shams university faculty of medicine

Other Identifiers

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ACTS004367

Identifier Type: -

Identifier Source: org_study_id

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