Using cold stored whole blood for patients in cardiothoracic surgery
Cold Stored Whole Blood in Treatment of Bleeding in Patients Undergoing Cardiothoracic Surgery
This study is testing whether using whole blood stored for different lengths of time can improve recovery for patients having complex heart surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen) |
| Trial ID | NCT04988620 on ClinicalTrials.gov |
What this trial studies
This pilot randomized clinical trial investigates the effects of storage time on whole blood transfusions in patients undergoing complex cardiothoracic surgery. Participants will be divided into two groups: one receiving whole blood stored for 15-21 days and the other receiving blood stored for less than 7 days. The study aims to assess the impact of storage duration on platelet function and post-transfusion recovery, providing insights for future larger trials. The goal is to enhance the safety and effectiveness of blood transfusions in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing complex cardiothoracic, cardiac, or aortic surgeries with expected cardiopulmonary bypass times over 120 minutes.
Not a fit: Patients with congenital coagulopathies, known antibodies, or those at increased surgical risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve transfusion practices and patient outcomes in cardiothoracic surgery by optimizing blood storage protocols.
How similar studies have performed: While this approach is exploratory, similar studies have indicated the importance of storage time on blood transfusion efficacy, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Study coordinator: Torunn O Apelseth, PhD
- Email: torunn.oveland.apelseth@helse-bergen.no
- Phone: +4755972470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.