Blood RecoveryNCT05545956
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
A study testing Hand Wrung and ProCell Wrung in people with Blood Recovery, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Blood Recovery
- What is being tested?
- Hand Wrung and ProCell Wrung
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
- At University Hospitals Cleveland Medical Center.
Who cannot join
- Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);
- Patients undergoing emergent or emergent salvage surgery; and
- Patients actively participating in another clinical trial which could affect outcomes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.
- Conditions
- Blood Recovery
- Being tested
- Hand Wrung, ProCell Wrung
- Keywords
- Open Heart Surgery, Heart Transplant, Lung Transplant, ProCell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand WrungProcedure or surgery
Hand wrung refers to manually wringing surgical sponges by hand.
ProCell WrungDevice
ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).
| Study group | Role | What they receive |
|---|---|---|
| Hand Wrung | Active comparator | Hand wrung refers to manually wringing surgical sponges by hand. Receives: Procedure: Hand Wrung |
| ProCell Wrung | Experimental | ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). Receives: Device: ProCell Wrung |
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of Packed Red Blood Cells Transfused
Units of packed red blood cells transfused will be measured.
Measured: Up to 72 Hours Post-Operative
Change in Level of Hematocrit
Level of hematocrit will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Plasma Free Hemoglobin
Level of plasma free hemoglobin will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Volume of Blood
Volume of blood will be measured at baseline and post-processing.
Measured: Baseline, Post-Processing (Up to 120 Minutes)
Secondary outcomes (6)
Change in Number of Fragmented Red Blood Cells
Number of fragmented red blood cells will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Lactate Dehydrogenase
Level of lactate dehydrogenase will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Haptoglobin
Level of haptoglobin will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Bilirubin
Level of bilirubin will be measured at baseline and post-operative.
Measured: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Weight of Surgical Sponge
Weight of surgical sponges will be measured at baseline and post-procedure.
Measured: Baseline, Post-Procedure (Up to 5 Minutes)
Time to Wring Sponges
Time in seconds to wring sponges will be measured.
Measured: Up to 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start9 May 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Why it stopped: Due staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood RecoveryStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ProCell Surgical Inc.
- Responsible party
- Sponsor
- Investigators
- Marc Pelletier, MD, Principal investigator, University Hospitals Cleveland Medical CenterCraig Jarrett, MD, MBA, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545956
- Sponsor's protocol ID
- STUDY20220888_2
- Status last verified
- Dec 2024
- First submitted
- 14 Sep 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
- ClinicalTrials.gov ID
- NCT05545956
- Acronym / sponsor ID
- STUDY20220888_2
- Conditions
- Blood Recovery
- Keywords
- Open Heart Surgery, Heart Transplant, Lung Transplant, ProCell
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due staffing issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- ProCell Surgical Inc.
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Wrung | Active comparator | Procedure: Hand WrungHand wrung refers to manually wringing surgical sponges by hand. |
| ProCell Wrung | Experimental | Device: ProCell WrungProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
- At University Hospitals Cleveland Medical Center.
Key exclusion criteria (3 listed)
- Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);
- Patients undergoing emergent or emergent salvage surgery; and
- Patients actively participating in another clinical trial which could affect outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand WrungHand wrung refers to manually wringing surgical sponges by hand. | Procedure or surgery | Hand Wrung |
| ProCell WrungProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell). | Device | ProCell Wrung |
Primary outcome
Units of Packed Red Blood Cells Transfused
Time frame: Up to 72 Hours Post-Operative
Units of packed red blood cells transfused will be measured.
Change in Level of Hematocrit
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Level of hematocrit will be measured at baseline and post-operative.
Change in Level of Plasma Free Hemoglobin
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Level of plasma free hemoglobin will be measured at baseline and post-operative.
Change in Volume of Blood
Time frame: Baseline, Post-Processing (Up to 120 Minutes)
Volume of blood will be measured at baseline and post-processing.
6 secondary outcomes
Change in Number of Fragmented Red Blood Cells
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Lactate Dehydrogenase
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Haptoglobin
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Level of Bilirubin
Time frame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
Change in Weight of Surgical Sponge
Time frame: Baseline, Post-Procedure (Up to 5 Minutes)
Time to Wring Sponges
Time frame: Up to 120 Minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Pelletier, MD principal investigator
University Hospitals Cleveland Medical Center
Craig Jarrett, MD, MBA principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Wrung and ProCell Wrung in people with Blood Recovery, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Units of Packed Red Blood Cells Transfused (time frame: Up to 72 Hours Post-Operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.