Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery

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

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2026-05-12

Brief Summary

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To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Blood prime for cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

blood use for priming cardiopulmonary bypass circuit

Intervention Type OTHER

one arm will have the cardiopulmonary bypass circuit primed with blood

clear prime for cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

clear prime for cardiopulmonary bypass

Intervention Type OTHER

this arm will not have bypass circuit primed with blood

Interventions

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blood use for priming cardiopulmonary bypass circuit

one arm will have the cardiopulmonary bypass circuit primed with blood

Intervention Type OTHER

clear prime for cardiopulmonary bypass

this arm will not have bypass circuit primed with blood

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient weight 3.5-12kg
* Elective and urgent cardiac surgery with cardiopulmonary bypass
* Cases within the STS STAT categories of 1-4

Exclusion Criteria

* Patients who weigh more than 12kg or less than 3.5kg.
* Patients undergoing emergency surgery.
* STAT category 5 cases.
* Patients whose surgery does not require cardiopulmonary bypass.
* Patients presenting preoperatively in shock.
* Patients with known blood dyscrasias.

Eligible Sex

ALL

Accepts Healthy Volunteers

No