Infection After TransfusionNCT02069210
The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
An observational study of Infection After Transfusion, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Infection After Transfusion
- What is being tested?
- Blood transfusion
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients underwent elective spine surgery
Who may be able to join
- Age > 18 - < 60 years
- Patients underwent elective spine surgery
- ASA classification 1-3
Who cannot join
- Patients who have the concomitant condition
- Cancer
- History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament.
- Serum creatinine > 1.5 mg/dL
- Stroke, neurologic and mental deficits, epilepsy
- General or local infection (site of surgery),
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- Coagulation disorders.
- Intraoperative massive bleeding
- Infection of the spine
- Rheumatoid arthritis
- Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Sirilak Suksompong
Bangkok, 10700
Sirilak Suksompong, MD, 66891534806, sirilak.suk@mahidol.ac.th
About this study
The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.
- Conditions
- Infection After Transfusion
- Being tested
- Blood transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Intraoperative blood transfusion
| Study group | Role | What they receive |
|---|---|---|
| Blood transfusion | Patients receive blood transfusion during operation Receives: Other: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic parameters
Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7.
- IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, Il-7, IL-8, Il-9, Il-10, Il-12, Il-13, IL-15, Il-17,basic FGF (Fibroblast growth factors).
- Cell Analytics - (mononuclear) T-Cells incl. killer cells, CD2, CD3, CD4, CD8, CD25, CD30, CD19, CD20, CD138, CD56, CD56, CD303, CD304, NK cytotoxicity (non-radioisotope), CTL cytotoxicity (non-radioisotope), T cell proliferation, B cell, T cell.
Measured: 7 days
Secondary outcomes (1)
To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMay 2014
- 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 Infection After TransfusionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Wolf-Schleinzer-Stiftung
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Study director, Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069210
- Sponsor's protocol ID
- SI 1
- Status last verified
- Feb 2014
- First submitted
- 17 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
- ClinicalTrials.gov ID
- NCT02069210
- Acronym / sponsor ID
- SI 1
- Conditions
- Infection After Transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Wolf-Schleinzer-Stiftung
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Feb 2014 (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.
The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood transfusion | – | Other: Blood transfusionPatients receive blood transfusion during operation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients underwent elective spine surgery
Key inclusion criteria (3 listed)
- Age > 18 - < 60 years
- Patients underwent elective spine surgery
- ASA classification 1-3
Key exclusion criteria (11 listed)
- Patients who have the concomitant condition
- Cancer
- History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament.
- Serum creatinine > 1.5 mg/dL
- Stroke, neurologic and mental deficits, epilepsy
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 transfusionIntraoperative blood transfusion | Other | Blood transfusion |
Primary outcome
Immunologic parameters
Time frame: 7 days
Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7. 1. IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, Il-7, IL-8, Il-9, Il-10, Il-12, Il-13, IL-15, Il-17,basic FGF (Fibroblast growth factors). 2. Cell Analytics - (mononuclear) T-Cells incl. killer cells, CD2, CD3, CD4, CD8, CD25, CD30, CD19, CD20, CD138, CD56, CD56, CD303, CD304, NK cytotoxicity (non-radioisotope), CTL cytotoxicity (non-radioisotope), T cell proliferation, B cell, T cell.
1 secondary outcome
To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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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.
Sirilak Suksompong, MD study director
Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
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 Infection After Transfusion, run by Mahidol University at 1 site in Thailand.
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 11 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 24 Feb 2014. 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 Thailand. 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?
Contact Sirilak Suksompong, MD (66891534806, sirilak.suk@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunologic parameters (time frame: 7 days). 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 Feb 2014.