Clinical trial NCT04988620: Cold Stored Whole Blood in Cardiothoracic Surgery
Official title: Cold Stored Whole Blood in Treatment of Bleeding in Patients Undergoing Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bleeding
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood loss
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Blood usage
timeFrame: 24 hours (8:00 am morning after surgery)
Secondary outcomes:
measure: INR
timeFrame: 24 hours (8:00 am morning after surgery)
measure: APTT
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Thromboelastography
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Platelet aggregometry
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Platelet count
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Hemoglobin concentration
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Erythrocyte count
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Hematocrit
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Fibrinogen concentration
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Metabolomic profile
timeFrame: 24 hours (8:00 am morning after surgery)
measure: White blood cell count
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Bilirubin
timeFrame: Up to 7 days
measure: Haptoglobin
timeFrame: Up to 7 days
measure: Lactate dehydrogenase
timeFrame: Up to 7 days
measure: Direct antiglobin test
timeFrame: Up to 7 days
measure: Anti-A antibodies
timeFrame: Up to 7 days
measure: Anti-B antibodies
timeFrame: Up to 7 days
measure: Hemostatic agents
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Other medications
timeFrame: 24 hours (8:00 am morning after surgery)
measure: Adverse events
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Helse Bergen
name: Einar K Kristoffersen, PhD
role: STUDY_CHAIR
References: