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NCT06743113 · ClinicalTrials.gov registry record · NA

Hypoxic Red Blood Cells in Sickle Cell Anemia

A NA study, sponsored by Hemanext.

Not yet
Registry status
NA
Development phase
48
Enrollment target

NCT06743113: Clinical Trial NA study, sponsored by Hemanext.

NCT06743113 is a NA study that has not yet begun recruiting, run by Hemanext. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06743113, a NA study, has not yet begun recruiting, sponsored by Hemanext.

NOT YET RECRUITING
Registry status
NA
Development phase
48 participants
Enrollment target

Study Summary

The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.

Primary Outcome

The primary objective is to evaluate the decreased rate of decline of %HbA between post-transfusion RCE and the subsequent pre-transfusion RCE over 6 transfusion cycles in the hypoxic RBC group compared to the conventional group.

Interventions

  • DEVICE Hemanext ONE System
  • DEVICE Conventional RBCs

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2026-03
Est. Completion 2028-09
Phase NA
Hemanext

2 total trials

What is known before NCT06743113 opens enrollment

NCT06743113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Hemanext ONE System is the first listed.

NCT06743113 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06743113 about?

NCT06743113 is a clinical study titled "Hypoxic Red Blood Cells in Sickle Cell Anemia". The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.

What is the current status of trial NCT06743113?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2026-03. Estimated completion is 2028-09.

What interventions are being tested in trial NCT06743113?

The interventions under investigation include: Hemanext ONE System (DEVICE), Conventional RBCs (DEVICE).

Who is sponsoring clinical trial NCT06743113?

This trial is sponsored by Hemanext, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06743113's enrollment target sits among peer trials

48 1381st of 2000 higher than 601 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06743113, the US trial registry maintained by the National Library of Medicine. NCT06743113 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.