Effects of Transfusion of Older Stored Red Cells

NCT01534676 | Terminated Results

• 2 other identifiers: AAAI1111R01HL098014
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Thalassemia

Keywords

iron; transfusion; red blood cells; sickle cell disease; thalassemia; blood donors

Outcome Measures

Primary Outcomes (1)

• Non-transferrin-bound Iron Level

  2 hours after transfusion

Study Arms (4)

Transfusion of Fresh blood

ACTIVE COMPARATOR

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; Biological: Blood; Procedure: Chelation therapy

Transfusion of Stored blood

EXPERIMENTAL

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; Biological: Blood; Procedure: Chelation therapy

Transfusion of Cryopreserved Blood

ACTIVE COMPARATOR

The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.

Procedure: Transfusion; Biological: Blood

Transfusion of Washed Blood

ACTIVE COMPARATOR

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; Biological: Blood

Interventions

Transfusion PROCEDURE

A routine medical procedure to transfuse packed red blood cells.

Also known as: RBC transfusion

Transfusion of Cryopreserved Blood; Transfusion of Fresh blood; Transfusion of Stored blood; Transfusion of Washed Blood

Blood BIOLOGICAL

Processing of RBC for transfusion include the following: * Fresh * Stored * Washed * Frozen (Cryopreserved)

Also known as: RBC product, Reb Blood Cells

Transfusion of Cryopreserved Blood; Transfusion of Fresh blood; Transfusion of Stored blood; Transfusion of Washed Blood

Chelation therapy PROCEDURE

(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.

Transfusion of Fresh blood; Transfusion of Stored blood

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• clinically unstable
• treatment for mental illness
• imprisonment
• institutionalization
• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Thalassemia

Interventions

Blood Transfusion; Blood Specimen Collection; Chelation Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Drug Therapy

Results Point of Contact

• Title: Eldad Hod, MD
• Organization: Columbia University Medical Center

eh2217@cumc.columbia.edu

212-342-5648

Study Officials

• Steven Spitalnik, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology and Cell Biology

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 5, 2016
• Results First Posted: October 5, 2016

Record last verified: 2016-08

Locations

US (1)