CoagulopathyNCT01912547
Thromboelastography During Surgery for Malignant Pleural Mesothelioma
An observational study of Coagulopathy and Mesothelioma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulopathy, Mesothelioma
- What is being tested?
- Blood draw for TEG analysis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing surgery for malignant pleural mesothelioma
Who may be able to join
- Adult male or female patients undergoing elective surgery for malignant pleural mesothelioma
Who cannot join
- Unwilling or unable to provide consent
- History of bleeding disorder
- On medications that may affect hemostasis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ju-Mei Ng, MD, 617-732-8219, jng1@partners.org
Ju-Mei Ng
About this study
Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.
Read the detailed description
Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery
- Conditions
- Coagulopathy, Mesothelioma
- Being tested
- Blood draw for TEG analysis
- Medical subject headings
- Hemostatic Disorders, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for TEG analysisProcedure or surgery
Blood drawn for TEG analysis
| Study group | Role | What they receive |
|---|---|---|
| Blood draw for TEG analysis | TEG analysis of blood from patients at different points in time Receives: Procedure: Blood draw for TEG analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation profile during extrapleural pneumonectomy or pleurectomy
Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery
Measured: Surgical period (4-6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju-Mei Ng, Brigham and Women's Hospital
- Investigators
- Ju-Mei Ng, MD, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912547
- Sponsor's protocol ID
- 2013P000653
- Status last verified
- Jan 2015
- First submitted
- 27 Jul 2013
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastography During Surgery for Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT01912547
- Acronym / sponsor ID
- 2013P000653
- Conditions
- Coagulopathy, Mesothelioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Jul 2013 (estimated)
- 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.
Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.
Detailed description
Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw for TEG analysis | – | Procedure: Blood draw for TEG analysisTEG analysis of blood from patients at different points in time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgery for malignant pleural mesothelioma
Key inclusion criteria (1 listed)
- Adult male or female patients undergoing elective surgery for malignant pleural mesothelioma
Key exclusion criteria (3 listed)
- Unwilling or unable to provide consent
- History of bleeding disorder
- On medications that may affect hemostasis
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 |
|---|---|---|
| Blood draw for TEG analysisBlood drawn for TEG analysis | Procedure or surgery | Blood draw for TEG analysis |
Primary outcome
Coagulation profile during extrapleural pneumonectomy or pleurectomy
Time frame: Surgical period (4-6 hours)
Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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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.
Ju-Mei Ng, MD principal investigator
BWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy and Mesothelioma, run by Brigham and Women's Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 30 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coagulation profile during extrapleural pneumonectomy or pleurectomy (time frame: Surgical period (4-6 hours)). 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 30 Jan 2015.