Retransfusion or Not of Cardiotomy Blood

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

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).

Study Overview

• Status: Unknown
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Procedure: No retransfusion of cardiotomy blood

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Wistrand, PhD; Phone Number: +460707686938; Email: camilla.wistrand@regionorebrolan.se

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • University Hospital in Örebro
    • Contact: Camilla Wistrand, PhD; Phone Number: +46707686938; Email: camilla.wistrand@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective CABG.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 retransfusion of cardiotomy blood via heart- and lung mashine
No Intervention: No retransfusion of cardiotomy blood

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Investigators: Principal Investigator: Camilla Wistrand, PhD, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: ECC 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No