Cold Stored Whole Blood in Cardiothoracic Surgery

Bleeding Clinical Trial

Official title:

Cold Stored Whole Blood in Treatment of Bleeding in Patients Undergoing Cardiothoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988620
• Other study ID #: 2019/01294
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Haukeland University Hospital
• Contact: Torunn O Apelseth, PhD
• Phone: +4755972470
• Email: torunn.oveland.apelseth[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Other:
• Whole Blood transfusion
In this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Blood usage	Comparison of amount of whole blood and blood components given	24 hours (8:00 am morning after surgery)
Secondary	INR	Coagulation measured as INR	24 hours (8:00 am morning after surgery)
Secondary	APTT	Coagulation measured as APTT	24 hours (8:00 am morning after surgery)
Secondary	Thromboelastography	Thromboelastography (TEG6s)	24 hours (8:00 am morning after surgery)
Secondary	Platelet aggregometry	Platelet aggregation measured by Multiplate impedance aggregometry (Mulitplate analyzer)	24 hours (8:00 am morning after surgery)
Secondary	Platelet count	Platelet count	24 hours (8:00 am morning after surgery)
Secondary	Hemoglobin concentration	Hemoglobin concentration	24 hours (8:00 am morning after surgery)
Secondary	Erythrocyte count	Erythrocyte count	24 hours (8:00 am morning after surgery)
Secondary	Hematocrit	Hematocrit or erytrocyte volume fraction, i.e.the volume percentage (vol%) of red blood cells (RBC) in blood,	24 hours (8:00 am morning after surgery)
Secondary	Fibrinogen concentration	Fibrinogen concentration	24 hours (8:00 am morning after surgery)
Secondary	Metabolomic profile	Investigation of blood cell metabolism and metabolic profile by use of high resolution mass spectometry	24 hours (8:00 am morning after surgery)
Secondary	White blood cell count	White blood cell count	24 hours (8:00 am morning after surgery)
Secondary	Bilirubin	Hemolysis measured as Bilirubin	Up to 7 days
Secondary	Haptoglobin	Hemolysis measured as Haptoglobin	Up to 7 days
Secondary	Lactate dehydrogenase	Lactate dehydrogenase (LD)	Up to 7 days
Secondary	Direct antiglobin test	Direct antiglobin test (DAT)	Up to 7 days
Secondary	Anti-A antibodies	Anti-A antibodies	Up to 7 days
Secondary	Anti-B antibodies	Anti-B antibodies	Up to 7 days
Secondary	Hemostatic agents	Use of hemostatic agents (coagulation factor concentrates, fibriongen concentrate)	24 hours (8:00 am morning after surgery)
Secondary	Other medications	Use of other medications potentially affecting bleeding (including tranexamacid, calcium etc.)	24 hours (8:00 am morning after surgery)
Secondary	Adverse events	Adverse events	30 days
Secondary	Length of stay	Length of stay	30 days
Secondary	Mortality	Mortality	30 days