Cold Stored Whole Blood in Cardiothoracic Surgery

Haukeland University Hospital

Status: Enrolling

Conditions: Bleeding

Treatments: Other: Whole Blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04988620

2019/01294

Details and patient eligibility

About

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.

Full description

A challenge for implementation of Whole Blood programs in civilian health services has been an uncertainty regarding the impact of storage on the clinical effect of the whole blood transfusion, especially when it comes to platelet function which is essential to hemostasis. In vitro platelet function and post-transfusion platelet recovery decline with increasing storage time of the whole blood.

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. A control group receiving standard care (blood component-based transfusion) may be included.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients not capable of providing informed consent to participate or who will not provide informed consent

2. Patients with known congenital coagulopathies or hemostatic disorders (von Willebrands Disease, hemophilia etc)

3. Patients with known erythrocyte- or platelet/HLA antibodies

4. Patients with a particular increased surgical risk with expected need of ECMO

5. Patients with preoperative EuroScore II ≥ 30

6. RhD negative patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Whole Blood stored for 15-21 days

Experimental group

Description:

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

Treatment:

Other: Whole Blood transfusion

Whole Blood stored for less than 7 days

Active Comparator group

Description:

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.

Treatment:

Other: Whole Blood transfusion

Whole Blood stored for 8-14 days

Active Comparator group

Description:

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.

Treatment:

Other: Whole Blood transfusion

Standard Blood Component

Active Comparator group

Description:

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

Treatment:

Other: Whole Blood transfusion