Clinical trial NCT05545956: Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
Official title: Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell): Delayed Impact
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Recovery
Keywords: Open Heart Surgery
Heart Transplant
Lung Transplant
ProCell
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: ProCell Surgical Inc.
First posted: 2022-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.


Eligibility criteria: Inclusion Criteria:

* Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
* At University Hospitals Cleveland Medical Center.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Units of Packed Red Blood Cells Transfused
timeFrame: Up to 72 Hours Post-Operative
measure: Change in Level of Hematocrit
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Level of Plasma Free Hemoglobin
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Volume of Blood
timeFrame: Baseline, Post-Processing (Up to 120 Minutes)
Secondary outcomes:
measure: Change in Number of Fragmented Red Blood Cells
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Level of Lactate Dehydrogenase
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Level of Haptoglobin
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Level of Bilirubin
timeFrame: Baseline, Post-Operative Hours 0, 6, 12, 18, 24, 48, and 72
measure: Change in Weight of Surgical Sponge
timeFrame: Baseline, Post-Procedure (Up to 5 Minutes)
measure: Time to Wring Sponges
timeFrame: Up to 120 Minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Marc Pelletier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Craig Jarrett, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: