CClinicalTrials.gg
Status unknownNCT04574128Updated Oct 5, 2020

Retransfusion or Not of Cardiotomy Blood

An interventional study of No retransfusion of cardiotomy blood in Blood Loss, Surgical, sponsored by Örebro University, Sweden. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Blood Loss, Surgical
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Örebro University, Sweden is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective CABG.

Exclusion criteria

Exclusion Criteria:

  • Anaemia, infection, massive bleeding, CABG off pump.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Retransfusion of cardiotomy blood or not

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

    Procedure: No retransfusion of cardiotomy blood

  • No intervention
    No retransfusion of cardiotomy blood

Interventions

  • ProcedureNo retransfusion of cardiotomy blood

    No retransfusion of cardiotomy blood via heart- and lung mashine

06

What researchers measure

Primary outcomes

  1. blood loss

    Hemoglobin

    Time frame: During 5 days hemoglobin will be measured as the clinical rutine or as needed.

  2. Blood loss

    Blood volume in millilitre (mL)

    Time frame: During 2 days or while surgical drains remains, blood volume in mL is measured.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — The datasets generated and/or analysed during the current study are not publicly available due to ethical considerations of the participant integrity. Bacterial growth can be seen as sensitive data. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574128
Lead sponsor
Örebro University, Sweden
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Oct 5, 2020

Study contacts

Camilla Wistrand, PhD
Contact
camilla.wistrand@regionorebrolan.se
+460707686938
Camilla Wistrand, PhD
principal investigator · Örebro University, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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