Cold Stored Whole Blood in Cardiothoracic Surgery

NCT04988620 | Unknown

• 1 other identifier: 2019/01294
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days.

Conditions

Bleeding

Outcome Measures

Primary Outcomes (2)

• Blood loss

  Comparison of postoperative immediate blood loss (measured by chest drain output and/or bleeding score) in patients receiving fresher or older cold stored whole blood.

  24 hours (8:00 am morning after surgery)

• Blood usage

  Comparison of amount of whole blood and blood components given

  24 hours (8:00 am morning after surgery)

Secondary Outcomes (22)

• INR

  24 hours (8:00 am morning after surgery)

• APTT

  24 hours (8:00 am morning after surgery)

• Thromboelastography

  24 hours (8:00 am morning after surgery)

• Platelet aggregometry

  24 hours (8:00 am morning after surgery)

• Platelet count

  24 hours (8:00 am morning after surgery)

Study Arms (4)

Whole Blood stored for 15-21 days

EXPERIMENTAL

CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 15-21 days

Other: Whole Blood transfusion

Whole Blood stored for less than 7 days

ACTIVE COMPARATOR

CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for less than 7 days. We aim at using as fresh as possible.

Other: Whole Blood transfusion

Whole Blood stored for 8-14 days

ACTIVE COMPARATOR

CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 8-14 days. This group may be added if deemed of interest after interim analysis.

Other: Whole Blood transfusion

Standard Blood Component

ACTIVE COMPARATOR

This group may be added for comparison if deemed of interest after interim analysis.

Other: Whole Blood transfusion

Interventions

Whole Blood transfusion OTHER

In this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood.

Standard Blood Component; Whole Blood stored for 15-21 days; Whole Blood stored for 8-14 days; Whole Blood stored for less than 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cardiothoracic, cardiac, or aortic surgery
• Patients with complex surgical procedures and expected cardiopulmonary bypass (CPB) time over 120 minutes
• Patients capable of providing informed consent to participate in the study

You may not qualify if:

• Patients not capable of providing informed consent to participate or who will not provide informed consent
• Patients with known congenital coagulopathies or hemostatic disorders (von Willebrands Disease, hemophilia etc)
• Patients with known erythrocyte- or platelet/HLA antibodies
• Patients with a particular increased surgical risk with expected need of ECMO
• Patients with preoperative EuroScore II ≥ 30
• \. RhD negative patient

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Exchange Transfusion, Whole Blood

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Einar K Kristoffersen, PhD

  Helse Bergen

  STUDY CHAIR

Central Study Contacts

Torunn O Apelseth, PhD

CONTACT

+4755972470; torunn.oveland.apelseth@helse-bergen.no

Kristin G Hagen, MD

CONTACT

+4755972470; kristin.gjerde.hagen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant and clinical personell ordering and evalutaing the effect of transfusion will be blinded, so will also the investigators performing the statistical evaluation of the results. The project co-workers preparing the whole blood units and perforing laboratory analysis will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Test group ( Whole Blood stored for 15-21 days) versus Control group(s) (Whole Blood stored for less than 7 days, Whole Blood stored for 8-14 days and/or Standard Blood Component treatment)

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: August 3, 2021
• Study Start: June 4, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)