Red blood cells for Blood Transfusions

Phase-Based Estimates
1
Effectiveness
1
Safety
Kingston Health Sciences Centre, Kingston, Canada
Red blood cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Blood Transfusions

Study Summary

This study is evaluating whether giving male patients female blood and female patients male blood (sex-mismatched blood) is better for patients than giving male patients male blood and female patients female blood (sex-matched blood).

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Red blood cells will improve 3 primary outcomes and 9 other outcomes in patients with Blood Transfusions. Measurement will happen over the course of From date of patient randomization until the date of death from any cause while in hospital, assessed up to 30 days after the final patient is randomized..

Day 30
Patient important clinical outcomes - Time to death (days)
Day 30
Patient important clinical outcomes - Creatinine level and increment (umol/L)
Patient important clinical outcomes - Hemoglobin increment (g/L)
Patient important clinical outcomes - ICU/hospital length of stay (days)
Patient important clinical outcomes - Number/type of transfused products (unit/volume)
Patient important clinical outcomes - Number/type of transfusion reactions
Day 30
Data collection outcome - Ability to provide timely monthly reports
Month 8
Feasibility outcome - Missing randomization rate (%)
Day 30
Data collection outcome - Rate of post-randomization exclusions (%)
Feasibility outcome - Protocol adherence (%)
Feasibility outcome - Recruitment compliance (%)
Patient important clinical outcomes - In-hospital mortality (%)

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Sex-matched red blood cell transfusion

This trial requires 270 total participants across 2 different treatment groups

This trial involves 2 different treatments. Red Blood Cells is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Sex-matched red blood cell transfusion
Biological
All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is matched to their sex (donor and recipient sex are the same). Patients in this arm will receive RBCs matched to their sex until discharge from hospital or death.
Sex-mismatched red blood cell transfusion
Biological
All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is not matched to their sex (donor and recipient sex are not the same). Patients in this arm will receive RBCs mismatched to their sex until discharge from hospital or death.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of study initiation at each site until date the final patient is randomized, approximately 8 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of study initiation at each site until date the final patient is randomized, approximately 8 months. for reporting.

Who is running the study

Principal Investigator
M. Z.
Prof. Michelle Zeller, Associate Professor
McMaster University

Closest Location

Kingston Health Sciences Centre - Kingston, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults (age ≥18)
Admitted to the intensive care unit
Requiring a red blood cell transfusion

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for blood transfusions?

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In this review, common treatments for blood transfusions include 1) whole blood in general, 2) packed red blood cells for hemolytic (non-A-B D) transfusions, and 3) platelets in general as well as when platelets are used in prophylaxis, the first transfusion of RBCs, or in massive blood loss or in bleeding patients. Other important blood products that are only partially used now are plasma and cryoprecipitate.

Unverified Answer

How many people get blood transfusions a year in the United States?

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The AHRQ estimates the number of blood transfusions received by all patients with the best estimates reported. Only for critically ill and bleeding patients does more than 80% of patients qualify for blood transfusions. The number needed to transfuse is fairly high, ranging between 2 and 22. A large number of blood units are being wasted and potentially unnecessary. The mean length of stay is 6 days for both patients without blood and patients receiving a blood transfusion (and 6.4 days for the transfused group). Many blood transfusions were performed on patients with a low risk for needing these procedures based on clinical prediction models.

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What are the signs of blood transfusions?

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Most commonly, blood transfusions are associated with bruising and anemia but rarely with new red or white cells and other symptoms. The occurrence of all these signs indicates that a person is not receiving good medical care, and their symptoms are likely to be improved by correcting their anemia.

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Can blood transfusions be cured?

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Blood transfusions may well not be the best treatment for a certain subgroup of patients with anemia. In patients with severe anemia undergoing blood transfusions, such as during obstetric-gynecological surgery, blood transfusions may be indicated because of their beneficial effect on morbidity, rather than their beneficial effect on survival.

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What causes blood transfusions?

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The overall incidence of blood transfusions in Ireland and Canada is very similar. Blood products are most commonly given for surgical or obstetrical indications. The use of platelet and blood products is higher when there is an increased risk of anaerobic infection. Transfusion of red blood cell based products is most commonly indicated due to anemia, anemia due to blood loss, severe co-morbidities and as a result of low haemoglobin, in patients with severe bleeding problems. The use of blood products is most commonly done in elective surgical patients. This indicates the need for audit, particularly the implementation of blood saving strategies.

Unverified Answer

What is blood transfusions?

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Blood transfusion is the most costly component of blood product use. However, blood transfusion results in fewer deaths and lower overall complication rates as compared with blood product use.

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What is red blood cells?

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In this patient who required a lengthy period of time to recover from a transfusion reaction after a [RBC] transfusion, the [RBC] may have improved the patient's condition.

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Is red blood cells typically used in combination with any other treatments?

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In this large study of Medicare D, we found RBC administration to be very rarely used without any other treatments. We also did not find an association between RBC transfusion and a worse outcome. In our view, it seems that blood products are frequently used with other therapies.

Unverified Answer

Does red blood cells improve quality of life for those with blood transfusions?

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A reduction in the frequency of transfusions is recommended despite its association with lower quality of life, given the poor quality of life and high cost of blood transfusions. Red blood cell transfusions have a very low impact on survival or hospital stay, even in those with multiple transfusions.

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What does red blood cells usually treat?

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Most patients treated with RBC transfusion therapy do better than expected at the end of treatment. However, some patients may remain unchanged or worsen during treatment with RBCs. These patients seem to progress more slowly than other patients with the same blood products and may require more blood products. Future research should assess the role of RBC transfusions in patients with non-ICU disease in hopes of reducing the number of unnecessary transfusions, and if available, assessing the best way to tailor the therapy to the needs of individual patients. All patients with ICU-acquired blood transfusions should be further evaluated.

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Have there been any new discoveries for treating blood transfusions?

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Over the past two decades, most clinical research has focused on preventing transfusions or on providing alternative and complementary therapies for transfusion needs. Few trials address alternative and complementary treatments aimed at reducing the number of transfusions required or reducing risk of transfusions; the evidence for most of these therapies is weak. There is a need for a rigorous systematic review of research in this field to assist with deciding future directions.

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What is the average age someone gets blood transfusions?

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There is an increased risk of severe anemia at an older age, although this risk is substantially lower as compared with younger people. However, a substantial difference was noted between the lowest (≤45 years old) and the highest (≥80) age groups. Because of this, a one-year transfusion deferral should not exceed age 45, at least in routine practice, given that the risks and adverse effects associated with this can outweigh the potential for transfusion and transfusion-related mortality.

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