Cold Stored Whole Blood in Cardiothoracic Surgery
- Conditions
- Bleeding
- Interventions
- Other: Whole Blood transfusion
- Registration Number
- NCT04988620
- Lead Sponsor
- Haukeland University Hospital
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole Blood stored for 15-21 days Whole Blood transfusion CPD Whole Blood leukoreduced with a platelet-sparing filter and stored cold for 15-21 days Whole Blood stored for less than 7 days Whole Blood transfusion 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. Whole Blood stored for 8-14 days Whole Blood transfusion 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. Standard Blood Component Whole Blood transfusion This group may be added for comparison if deemed of interest after interim analysis.
- Primary Outcome Measures
Name Time Method Blood usage 24 hours (8:00 am morning after surgery) Comparison of amount of whole blood and blood components given
Blood loss 24 hours (8:00 am morning after surgery) 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.
- Secondary Outcome Measures
Name Time Method White blood cell count 24 hours (8:00 am morning after surgery) White blood cell count
APTT 24 hours (8:00 am morning after surgery) Coagulation measured as APTT
Platelet aggregometry 24 hours (8:00 am morning after surgery) Platelet aggregation measured by Multiplate impedance aggregometry (Mulitplate analyzer)
Fibrinogen concentration 24 hours (8:00 am morning after surgery) Fibrinogen concentration
INR 24 hours (8:00 am morning after surgery) Coagulation measured as INR
Thromboelastography 24 hours (8:00 am morning after surgery) Thromboelastography (TEG6s)
Platelet count 24 hours (8:00 am morning after surgery) Platelet count
Hemoglobin concentration 24 hours (8:00 am morning after surgery) Hemoglobin concentration
Erythrocyte count 24 hours (8:00 am morning after surgery) Erythrocyte count
Hematocrit 24 hours (8:00 am morning after surgery) Hematocrit or erytrocyte volume fraction, i.e.the volume percentage (vol%) of red blood cells (RBC) in blood,
Metabolomic profile 24 hours (8:00 am morning after surgery) Investigation of blood cell metabolism and metabolic profile by use of high resolution mass spectometry
Bilirubin Up to 7 days Hemolysis measured as Bilirubin
Haptoglobin Up to 7 days Hemolysis measured as Haptoglobin
Lactate dehydrogenase Up to 7 days Lactate dehydrogenase (LD)
Hemostatic agents 24 hours (8:00 am morning after surgery) Use of hemostatic agents (coagulation factor concentrates, fibriongen concentrate)
Direct antiglobin test Up to 7 days Direct antiglobin test (DAT)
Anti-B antibodies Up to 7 days Anti-B antibodies
Adverse events 30 days Adverse events
Length of stay 30 days Length of stay
Mortality 30 days Mortality
Anti-A antibodies Up to 7 days Anti-A antibodies
Other medications 24 hours (8:00 am morning after surgery) Use of other medications potentially affecting bleeding (including tranexamacid, calcium etc.)
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway