Blood Loss, SurgicalNCT04933253
Mediastinal Temperature and Post-operative Bleeding
A study testing Saline irrigation in people with Blood Loss, Surgical, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will investigate how chest temperature relates to blood loss and blood clotting. Researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Saline irrigation
- Type of treatment
- 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
- Oct 2022to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing open cardiac surgery at VCU
- Age18 to 80 years
- American Society of Anesthesiologists Physical Status 1-3
Who cannot join
- history of excessive bleeding
- partial thromboplastin time > 35 s
- prothrombin time > 35 s
- fibrinogen < 200 mg/dL
- platelet count < 100,000/L
- history of infection and fever within 4 weeks before surgery
- use of steroid or immunosuppressant within 4 weeks before surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study will investigate how chest temperature relates to blood loss and blood clotting. Researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. In addition, researchers will test if warm irrigation of the chest increases the temperature of the chest and if this impacts blood loss.
Read the detailed description
Low body temperature during surgery, defined as a temperature below 34 °C, occurs commonly in patients undergoing cardiac surgery due to the bypass machine and an open chest. Low body temperature has been associated with blood loss, but the relevant published data are inconclusive. Nevertheless, evidence suggests that blood loss during and after surgery are higher in low body temperature patients than in the normal body temperature patients. In addition, low body temperature can impair blood clotting. The clinical significance of this is high as it is well established that blood transfusion increases mortality after surgery.
- Conditions
- Blood Loss, Surgical
- Being tested
- Saline irrigation
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline irrigationProcedure or surgery
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest Receives: Procedure: Saline irrigation |
| Control | No intervention | this cohort will receive the normal standard of care as established by the primary surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest temperature
We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Measured: At the end of surgery, up to 5 hours
Amount of blood loss
amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study startOct 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Recruitment has been unsuccessful and the study team is withdrawing the study while they consider options and alternatives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo Cardounel, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933253
- Sponsor's protocol ID
- HM20021183
- Status last verified
- Oct 2022
- First submitted
- 14 Jun 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediastinal Temperature and Post-operative Bleeding
- ClinicalTrials.gov ID
- NCT04933253
- Acronym / sponsor ID
- HM20021183
- Conditions
- Blood Loss, Surgical
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment has been unsuccessful and the study team is withdrawing the study while they consider options and alternatives.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 Jun 2021 (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.
This study will investigate how chest temperature relates to blood loss and blood clotting. Researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. In addition, researchers will test if warm irrigation of the chest increases the temperature of the chest and if this impacts blood loss.
Detailed description
Low body temperature during surgery, defined as a temperature below 34 °C, occurs commonly in patients undergoing cardiac surgery due to the bypass machine and an open chest. Low body temperature has been associated with blood loss, but the relevant published data are inconclusive. Nevertheless, evidence suggests that blood loss during and after surgery are higher in low body temperature patients than in the normal body temperature patients. In addition, low body temperature can impair blood clotting. The clinical significance of this is high as it is well established that blood transfusion increases mortality after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Saline irrigationthis cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest |
| Control | No intervention | –this cohort will receive the normal standard of care as established by the primary surgeon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing open cardiac surgery at VCU
- Age18 to 80 years
- American Society of Anesthesiologists Physical Status 1-3
Key exclusion criteria (7 listed)
- history of excessive bleeding
- partial thromboplastin time > 35 s
- prothrombin time > 35 s
- fibrinogen < 200 mg/dL
- platelet count < 100,000/L
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 |
|---|---|---|
| Saline irrigationMediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure | Procedure or surgery | Experimental |
Primary outcome
Chest temperature
Time frame: At the end of surgery, up to 5 hours
We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Amount of blood loss
Time frame: 24 hours after the end of surgery
amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery
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 28 Oct 2022.
- 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.
Arturo Cardounel, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline irrigation in people with Blood Loss, Surgical, run by Virginia Commonwealth University 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 3 inclusion and 7 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 28 Oct 2022. 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?
Chest temperature (time frame: At the end of surgery, up to 5 hours). The study lists 2 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 28 Oct 2022.