Transfusion of Whole Blood in Acute Bleeding

NCT06019364 | Enrolling By Invitation

• 1 other identifier: 280695
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Blood collected from blood donors is routinely divided into its different components, red blood cells, plasma and platelets. These components are stored under different storage conditions and their maximum storage time before transfusion is different. Platelets are stored at a maximum of 7 days and at a temperature of 22°C to best preserve their function. Research has been conduction on blood stored and transfused as whole blood (without separation into the various components), particularly in situations of acute trauma. Region Örebro län will therefore start transfusion of whole blood in such situations. The whole blood units will be stored at 4°C for a maximum of 14 days. This means that the platelets will be stored at a lower temperature than standard and for a longer time period. The research on how this will affect platelet function is limited. This project aims to determine how the patients are affected regarding coagulation, hemolysis, renal function, immunisation, transfusion reactions and the effect of substances released from the blood cells in the whole blood units during the storage period and if there is an impact on mortality.

Conditions

Blood Transfusion; Acute Bleeding

Outcome Measures

Primary Outcomes (3)

• Mortality

  Death within 30 days following the transfusion of whole blood

  30 day mortality

• Effect of the whole blood transfusion on coagulation

  Requirement for other transfusions

  All transfusions occuring within 24 hours post transfusion of the whole blood unit

• Bleeding

  Bleeding following transfusion of the whole blood unit

  All transfusions occuring within 24 hours post transfusion of the whole blood unit

Secondary Outcomes (32)

• Hemolysis

  Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30

• Platelet count

  Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30

• Red blood cell count

  Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 2, Day 5, Day 30

• APTT, a marker of coagulation capacity

  Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30

• PT, a marker of coagulation capacity

  Day 0-pre transfusion, Day 0-post transfusion, Day 1, Day 5 and Day 30

Interventions

Whole blood transfusion OTHER

Transfusion of whole blood in a situation with acute bleeding according to routine practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with acute bleeding that are transfused with whole blood at the time of the acute bleeding episode.

You may qualify if:

• Patient with acute bleeding
• Transfused with whole blood at the time of the acute bleeding episode

You may not qualify if:

• Patients where vital information lacking needed to interpret data (i.e. blood cell count)

Sponsors & Collaborators

• Sofia Ramström: lead

Study Sites (1)

Örebro University

Örebro, 70182, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples without DNA retained from the patient (plasma and serum)

MeSH Terms

Interventions

Exchange Transfusion, Whole Blood

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Sofia Ramström, Ass. Prof

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 31, 2023
• Study Start: September 10, 2023
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)