Cold Stored Whole Blood in Cardiothoracic Surgery
NCT04988620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-08-03
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.
Conditions
Interventions
- OTHER
-
Whole Blood transfusion
In this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood.
Sponsors & Collaborators
-
Haukeland University Hospital
lead OTHER
Principal Investigators
-
Einar K Kristoffersen, PhD · Helse Bergen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-04
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Norway
Study Locations
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