Cold Stored Whole Blood in Cardiothoracic Surgery

Haukeland University Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 5\. RhD negative patient

Outcomes

Primary Outcomes

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.

Time frame: 24 hours (8:00 am morning after surgery)

Blood usage

Comparison of amount of whole blood and blood components given

Time frame: 24 hours (8:00 am morning after surgery)

Secondary Outcomes

INR

Coagulation measured as INR

Time frame: 24 hours (8:00 am morning after surgery)

APTT

Coagulation measured as APTT

Time frame: 24 hours (8:00 am morning after surgery)

Thromboelastography

Thromboelastography (TEG6s)

Time frame: 24 hours (8:00 am morning after surgery)

Platelet aggregometry

Platelet aggregation measured by Multiplate impedance aggregometry (Mulitplate analyzer)

Time frame: 24 hours (8:00 am morning after surgery)

Platelet count

Time frame: 24 hours (8:00 am morning after surgery)

Hemoglobin concentration

Time frame: 24 hours (8:00 am morning after surgery)

Erythrocyte count

Time frame: 24 hours (8:00 am morning after surgery)

Hematocrit

Hematocrit or erytrocyte volume fraction, i.e.the volume percentage (vol%) of red blood cells (RBC) in blood,

Time frame: 24 hours (8:00 am morning after surgery)

Fibrinogen concentration

Time frame: 24 hours (8:00 am morning after surgery)

Metabolomic profile

Investigation of blood cell metabolism and metabolic profile by use of high resolution mass spectometry

Time frame: 24 hours (8:00 am morning after surgery)

White blood cell count

Time frame: 24 hours (8:00 am morning after surgery)

Bilirubin

Hemolysis measured as Bilirubin

Time frame: Up to 7 days

Haptoglobin

Hemolysis measured as Haptoglobin

Time frame: Up to 7 days

Lactate dehydrogenase

Lactate dehydrogenase (LD)

Time frame: Up to 7 days

Direct antiglobin test

Direct antiglobin test (DAT)

Time frame: Up to 7 days

Anti-A antibodies

Time frame: Up to 7 days

Anti-B antibodies

Time frame: Up to 7 days

Hemostatic agents

Use of hemostatic agents (coagulation factor concentrates, fibriongen concentrate)

Time frame: 24 hours (8:00 am morning after surgery)

Other medications

Use of other medications potentially affecting bleeding (including tranexamacid, calcium etc.)

Time frame: 24 hours (8:00 am morning after surgery)

Adverse events

Time frame: 30 days

Length of stay

Time frame: 30 days

Mortality

Time frame: 30 days

Cold Stored Whole Blood in Cardiothoracic Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts