Retransfusion or Not of Cardiotomy Blood

Blood Loss, Surgical Clinical Trial

Official title:

Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04574128
• Other study ID #: ECC 2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2020
• Source: Örebro University, Sweden
• Contact: Camilla Wistrand, PhD
• Phone: +460707686938
• Email: camilla.wistrand[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective CABG.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Procedure:
• No retransfusion of cardiotomy blood
No retransfusion of cardiotomy blood via heart- and lung mashine

Locations

Country	Name	City	State
Sweden	University Hospital in Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss	Hemoglobin	During 5 days hemoglobin will be measured as the clinical rutine or as needed.
Primary	Blood loss	Blood volume in millilitre (mL)	During 2 days or while surgical drains remains, blood volume in mL is measured.