Resuscitation, Trauma PatientsTHAMNCT01326260
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)
An observational study of Resuscitation, Trauma Patients, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Resuscitation, Trauma Patients
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 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 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to San Francisco General Hospital from 2005 through 2009 with severe traumatic injury requiring emergent surgery who develop severe acidosis
Who may be able to join
- Presence of severe traumatic injury requiring emergent surgery
- Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL)
- Acidosis was treated with either THAM or "usual care" (defined as crystalloid either or without sodium bicarbonate)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco at San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study
This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.
Read the detailed description
The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.
- Conditions
- Resuscitation, Trauma Patients
- Keywords
- resuscitation, trauma, THAM, colloids, crystalloids
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| THAM Patients | Patients who were managed with the use of THAM | |
| Non-THAM Patients | Patients who did not use THAM but were resuscitated with crystalloids and colloids and may have received sodium bicarbonate for the treatment of acidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
Measured: Operative period and ICU (72 hr) post-op period
Secondary outcomes (1)
Intra-operative, intensive care unit and hospital mortality
Measure the the number of mortality during intra-operative and/or ICU period
Measured: From the operative procedure onset to discharge out of the ICU or expiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resuscitation, Trauma PatientsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julin Tang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326260
- Sponsor's protocol ID
- CHR 10-02652
- Acronym
- THAM
- Status last verified
- Feb 2020
- First submitted
- 29 Mar 2011
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT01326260
- Acronym / sponsor ID
- THAM / CHR 10-02652
- Conditions
- Resuscitation, Trauma Patients
- Keywords
- resuscitation, trauma, THAM, colloids, crystalloids
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Mar 2011 (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.
This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.
Detailed description
The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THAM Patients | – | –Patients who were managed with the use of THAM |
| Non-THAM Patients | – | –Patients who did not use THAM but were resuscitated with crystalloids and colloids and may have received sodium bicarbonate for the treatment of acidosis |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to San Francisco General Hospital from 2005 through 2009 with severe traumatic injury requiring emergent surgery who develop severe acidosis
Key inclusion criteria (3 listed)
- Presence of severe traumatic injury requiring emergent surgery
- Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL)
- Acidosis was treated with either THAM or "usual care" (defined as crystalloid either or without sodium bicarbonate)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
Time frame: Operative period and ICU (72 hr) post-op period
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
1 secondary outcome
Intra-operative, intensive care unit and hospital mortality
Time frame: From the operative procedure onset to discharge out of the ICU or expiration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Julin Tang, MD principal investigator
University of California, San Francisco
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 Resuscitation, Trauma Patients, run by University of California, San Francisco 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 1 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: stopped early, as of the sponsor's last update on 17 Feb 2020. 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 stopped early. Results are not available in the source record.
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?
Total amount of fluids and blood products used during the operative and 72 hr post-operative period. (time frame: Operative period and ICU (72 hr) post-op period). 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 17 Feb 2020.