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NCT01435304 · ClinicalTrials.gov registry record · NA
The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
A NA study, sponsored by MaineHealth.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01435304: Completed NA study, sponsored by MaineHealth.
NCT01435304 is a NA study that has completed, run by MaineHealth. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435304, a NA study, has completed, sponsored by MaineHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte solution) and loss of plasma proteins responsible for normal blood clotting as well as platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery (cardiac surgery performed without the use of blood or blood products). The system is designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary bypass) after it is separated from the patient during the performance of cardiac surgery. Consequently the likelihood of excessive post-operative bleeding and transfusion with allogeneic blood (blood bank blood from donors) is decreased.
Primary Outcome
Chest catheters are placed in the mediastinum and sometimes pleural space(s) to collect shed mediastinal blood in the first 24 hours post operative cardiac surgery
Interventions
- DEVICE method of returning residual CPB blood ( Hemobag®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01435304 record still lists
NCT01435304 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which method of returning residual CPB blood ( Hemobag®) is the first listed.
NCT01435304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01435304 about?
NCT01435304 is a clinical study titled "The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass". This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte solution) and loss of plasma proteins responsible for normal blood clotting as well as platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device qualified by the US Food and Drug ...
What is the current status of trial NCT01435304?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2011-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01435304?
The interventions under investigation include: method of returning residual CPB blood ( Hemobag®) (DEVICE).
Who is sponsoring clinical trial NCT01435304?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01435304's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 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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