Retransfusion or Not of Cardiotomy Blood

NCT ID: NCT04574128

Last Updated: 2020-10-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-30

Brief Summary

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This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).

Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomised controlled non-inferiority trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The person that controle the heart- and lung mashine is not masked. Other members of the surgical team is masked.

Study Groups

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Retransfusion of cardiotomy blood or not

Intervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does.

Group Type EXPERIMENTAL

No retransfusion of cardiotomy blood

Intervention Type PROCEDURE

No retransfusion of cardiotomy blood via heart- and lung mashine

No retransfusion of cardiotomy blood

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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No retransfusion of cardiotomy blood

No retransfusion of cardiotomy blood via heart- and lung mashine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective CABG.

Exclusion Criteria

* Anaemia, infection, massive bleeding, CABG off pump.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camilla Wistrand, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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University Hospital in Örebro

Örebro, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Camilla Wistrand, PhD

Role: CONTACT

+460707686938

Facility Contacts

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Camilla Wistrand, PhD

Role: primary

+46707686938

Other Identifiers

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ECC 2020

Identifier Type: -

Identifier Source: org_study_id

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