Effects of Transfusion of Older Stored Red Cells

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01534676
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 3
• Location: 1
• Arms: 4
• Duration (Months): 12.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.

The investigators hope to test:

• whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.

• whether washing or cryopreserving the red blood cells has any effect on this outcome.

These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease; Thalassemia	Procedure: Transfusion; Biological: Blood; Procedure: Chelation therapy	N/A

Detailed Description

Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transfusion of Fresh blood The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy.	Procedure: Transfusion; A routine medical procedure to transfuse packed red blood cells.; Other Names: RBC transfusion ; Biological: Blood; Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved); Other Names: RBC product Reb Blood Cells ; Procedure: Chelation therapy; (non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
Experimental: Transfusion of Stored blood The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy.	Procedure: Transfusion; A routine medical procedure to transfuse packed red blood cells.; Other Names: RBC transfusion ; Biological: Blood; Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved); Other Names: RBC product Reb Blood Cells ; Procedure: Chelation therapy; (non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
Active Comparator: Transfusion of Cryopreserved Blood The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.	Procedure: Transfusion; A routine medical procedure to transfuse packed red blood cells.; Other Names: RBC transfusion ; Biological: Blood; Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved); Other Names: RBC product Reb Blood Cells
Active Comparator: Transfusion of Washed Blood The recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy.	Procedure: Transfusion; A routine medical procedure to transfuse packed red blood cells.; Other Names: RBC transfusion ; Biological: Blood; Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved); Other Names: RBC product Reb Blood Cells

Outcome Measures

Primary Outcome Measures

1. Non-transferrin-bound Iron Level [2 hours after transfusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria (Recipient):

• specific, well-characterized hemoglobinopathy

• chronic simple transfusion therapy (transfusion episodes < 6 weeks apart in frequency)

• chronic iron chelation therapy

• not pregnant by self-report and not planning pregnancy

• age > 1 year old

Exclusion Criteria (Recipient):

• clinically unstable

• treatment for mental illness

• imprisonment

• institutionalization

Inclusion Criteria (Donor):

• 21-65 years of age

• male weight > 130 lbs, female weight > 150 lbs

• male height > 5'1", female height > 5'5"

• hemoglobin > 15.0 g/dL

• reasonably certain of intention to stay in New York City metropolitan area for study duration

• previously tolerated red blood cell donation

Exclusion Criteria (Donor):

• ineligible for donation based on New York Blood Center blood donor screening questionnaire

• systolic blood pressure < 90 or > 180 mm Hg, diastolic blood pressure < 50 or > 100 mm Hg

• heart rate < 50 or > 100

• temperature > 99.5 F prior to donation

• positive by standard infectious disease testing performed on blood donors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Steven Spitalnik, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven L. Spitalnik, Professor of Pathology and Cell Biology, Columbia University
• ClinicalTrials.gov Identifier: NCT01534676
• Other Study ID Numbers: AAAI1111; R01HL098014
• First Posted: Feb 17, 2012
• Last Update Posted: Oct 5, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Steven L. Spitalnik, Professor of Pathology and Cell Biology, Columbia University: iron; transfusion; red blood cells; sickle cell disease; thalassemia; blood donors
• Additional relevant MeSH terms: Anemia, Sickle Cell; Thalassemia

Study Results

Participant Flow

Recruitment Details	This is a research study carried out at Columbia University Medical Center. Participants with a blood disorder and currently receive blood transfusions as treatment will be transfused fresh, stored, washed or frozen blood according to regular schedule for up to 3 years. Volunteer dedicated donors will also be asked to provide consent.
Pre-assignment Detail	Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment.

Arm/Group Title	Recipients	Donors
Arm/Group Description	Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.	Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
Period Title: Overall Study
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Recipients	Donors	Total
Arm/Group Description	Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.	Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	2 100%	0 0%	2 66.7%
Between 18 and 65 years	0 0%	1 100%	1 33.3%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	1 100%	1 33.3%
Male	2 100%	0 0%	2 66.7%
Region of Enrollment (participants) [Number]
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Non-transferrin-bound Iron Level
Time Frame	2 hours after transfusion

Outcome Measure Data

Analysis Population Description

Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.

Arm/Group Title	Recipients	Donors
Arm/Group Description	Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.	Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Recipients		Donors
Arm/Group Description	Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.		Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
All Cause Mortality
	Recipients		Donors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Recipients		Donors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Recipients		Donors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.