Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Blood swap breakthrough: can exchange transfusions save sickle cell patients?

NCT ID NCT04084080

Disease control Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether automated red cell exchange (a procedure that replaces a patient's sickled red blood cells with healthy donor cells) plus standard care can reduce hospital visits and deaths in adults with sickle cell disease at high risk. About 173 participants will be randomly assigned to receive either the exchange transfusions or standard care alone, and researchers will track health events over 13 months. The goal is to see if this approach can prevent sudden worsening of the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

173 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Diagnosis of SCD: homozygous sickle cell disease, hemoglobin-SC, Sβ-thalassemia, hemoglobin-SO or hemoglobin-SD. * Patients not on a chronic exchange transfusion program for at least 60 days. * If patients are on a SCD drug (e.g. hydroxyurea, glutamine, or P-selectin inhibitors), the doses must be stable for at least 60 days prior to randomization. At the time of randomization, participants must be off Oxbryta for at least 30 days. * Any one of the following vasculopathy biomarker clinical results (a, b, c, d or e) measured in the last 24 months before randomization that indicates a high-risk patient: 1. Both a TRV 2.5- \<3.0 m/sec and NT-proBNP plasma level ≥ 160 pg/mL, 2. TRV ≥ 3.0 m/sec, 3. Both a mean pulmonary artery pressure (PAP) by right heart catheterization 20-24 mmHg and NT-proBNP plasma level ≥ 160 pg/mL, 4. Mean PAP by right heart catheterization ≥ 25 mmHg, 5. Chronic kidney disease (CKD) due to SCD with abnormal measures on 2 separate occasions as defined by: macroalbuminuria (albumin to creatinine ratio (ACR) \>300 mg/g) or proteinuria (protein to creatinine ratio \>30 mg/mmol), or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2. (It is recommended that local laboratories use Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation without ethnic factors when estimating and reporting GFR). Clinical results of these biomarkers measured locally at sites within 24 months prior to randomization are acceptable to determine eligibility. TRV, PAP, NT-proBNP, albumin to creatinine ratio, protein to creatinine ratio, or eGFR values must be measured in a steady state (defined as measured ≥ 14 days since an acute care pain event) on different days. vi. Written informed consent obtained from patient to participate in the trial. Exclusion Criteria: * RBC alloimmunization resulting in inability of blood bank to obtain compatible components for chronic exchange transfusions * Previous history of hyper-hemolysis syndrome * Previous history of severe transfusion reaction resulting in renal failure or due to serious complications such as hypotension or respiratory distress * More than 10 vaso-occlusive episodes in the past 12 months requiring admission to a hospital to receive treatment. * Religious objection to receiving blood transfusion * Diagnosis of ischemic stroke within the past 6 months * Clinical evidence of liver failure or advanced cirrhosis or any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the trial * Women of childbearing potential who have a positive pregnancy test at baseline

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sickle cell disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28204, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hemorio

    Rio de Janeiro, Brazil

  • Henri Mondor Hopital

    Paris, France

  • Howard University Center for Sickle Cell Disease

    Washington D.C., District of Columbia, 20060, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21206, United States

  • Kremlin-Bicêtre

    Créteil, France

  • Montefiore Medical Center

    New York, New York, 10461, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama

    Tuscaloosa, Alabama, 35401, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60607, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

  • Washington University-St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.