Incompatible Blood TransfusionNCT02140216
Immunomodulation Effect of Blood Transfusion
An observational study of Incompatible Blood Transfusion and Immune Defect, run by Mahidol University at 1 site in Thailand.
Trial summary
An increasing number of publications have demonstrated that homologous (allogeneic) blood transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood products cannot solve these problems, despite improved quality of red cells; a recent study demonstrated deteriorated outcome of cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Incompatible Blood Transfusion, Immune Defect, Surgery
- What is being tested?
- No blood transfusion, Day 0 blood transfusion and Day 1 or 2 blood transfusion
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to 10 Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective spine surgery/
Who may be able to join
- Patients undergoing elective spine surgery
- American Society of Anesthesiologist Risk score classification (ASA) I-III
- Hemoglobin > 9 gm/dL
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), coagulation disorders, rheumatoid arthritis.
- Patients who have one of the following drugs; aspirin, methotrexate, cyclosporin, qualaquin
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Allogeneic Red Cell Transfusion and Its Influence on Relevant Humoral and Cellular Immunological Parameters
An increasing number of publications have demonstrated that homologous (allogeneic) blood transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood products cannot solve these problems, despite improved quality of red cells; a recent study demonstrated deteriorated outcome of cancer patients with elective colon surgery and transfusion of leukocyte depleted allogeneic blood.
Read the detailed description
All patients undergo the identical anesthesiological procedure, including premedication, general anesthesia with endotracheal intubation, monitoring and postoperative pain therapy and mobilization.Surgery is performed by the identical team performing a standardized technique.
Transfusion regimen The 'trigger' for homologous red cell transfusion intra- and postoperatively is the actual hematocrit concentration. Transfusion depends on discretion of the treating physicians. Number of units transfused, amount of blood loss, time, reasoning and decision maker are recorded.
Blood samples Within the kind of surgical procedures chosen for this study the chance of red cell transfusion is about 60 - 70%. In terms of figures 10 non-transfused cases could be gained within 40 cases in total. However, transfusion or non-transfusion does not happen in a row. We expect the total number of patients with blood withdrawal to be between 50 and 60. Additionally withdrawn samples currently not used for analysis will stored for further studies.
The purpose to include non-transfused otherwise fully comparable patients is to distinguish between trauma (operation) and transfusion and their influence on immune modulation. Within the studies about blood transfusion and immune modulation only some few made this differentiation. In patients with colorectal cancer surgery randomized groups with autologous predonation and patients with allogeneic transfusion only have been compared. However, within the latter (allogeneic) group of 27 patients only 13 had to be transfused, thus creating a non-transfusion group of 14 patients. These 14 non-transfused patients remained within the study being compared with autologous and allogeneic transfused patients. Operative trauma and allogeneic transfusion both increased the secretion of several cytokines including tumor necrosis factor (TNF) alpha and Interleukin-10; this effect was less pronounced in patients with autologous- and without any transfusion. Another group studied forty three orthopedic patients with total knee- or hip-arthroplasty, initially to compare autologous to allogeneic red cell transfusion. They had to change their protocol due to the small number of allogeneic transfusions (8 of 43). Including perioperatively transfused patients only (n = 37) they found an increase in immune regulatory cytokine Interleukin (IL)-10 after red cell transfusion, which was most pronounced 7 days after surgery, whereas there was only a mild increase in non- or autologous transfused patients. Unfortunately they did not differentiate between autologous-and non-transfused patients. Thus their data could not reveal the effect of surgery itself on the analyzed parameters.
- Conditions
- Incompatible Blood Transfusion, Immune Defect, Surgery
- Being tested
- No blood transfusion, Day 0 blood transfusion, Day 1 or 2 blood transfusion
- Keywords
- Blood transfusion, Immune, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No blood transfusionBiological
No blood transfusion
Day 0 blood transfusionBiological
Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.
Day 1 or 2 blood transfusionBiological
Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Day 0 blood transfusion | Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion. Receives: Biological: Day 0 blood transfusion | |
| Day 1 or 2 blood transfusion | Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery. Receives: Biological: Day 1 or 2 blood transfusion | |
| No blood transfusion | Patients undergoing elective spine surgery receiving no blood transfusion. Receives: Biological: No blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrophage inflammatory protein 1 alpha (MIP-1a)
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
macrophage inflammatoryprotein 1 beta (MIP-1b)
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
platelet-derived growth factor-BB
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
RANTES
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
tumour TNF alpha
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
VEGF
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
Ferritin
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
Fibrinogen
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
procalcitonin
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
interleukin
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
basic fibroblast growth factor (B-FGF)
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
eotaxin (monocyte chemotactic proteins)
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
G-CSF
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
GM-CSF
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
IFN-alpha
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
IP-10
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
MCP-1
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
MCAF
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
serum amyloid A
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
tissue plasminogen activator
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
Postoperative non-surgical complications
Infection, thrombosis, pulmonary affection
Measured: 30 days
Secondary outcomes (15)
CD2 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD3 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD4 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 25 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 30 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 19 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 20 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 138 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 56 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 303 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CLT cytotoxicity (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
CD 304
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
NK cytotoxicity
Blood sample on preoperative, postoperative day 1, 3, 5
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completion18 Jun 2017
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incompatible Blood TransfusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Wolf Schleinzer Stiftung zur Wissenschafts- und Bildungsförderung, Germany
- Responsible party
- Principal investigator, Benno von Bormann, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140216
- Sponsor's protocol ID
- Si 081/2557 (EC3)
- Status last verified
- Aug 2021
- First submitted
- 5 May 2014
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008 Sep;36(9):2667-74. doi: 10.1097/CCM.0b013e3181844677.
PubMed 18679112von Bormann B, Wirtz S, Weiler J, von Bormann C, Trobisch H. [Quality of whole blood as a result of storage and preparation (inline-leukocyte depletion). Evidence for autologous predeposit]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2000 May;35(5):326-32. doi: 10.1055/s-2000-323. German.
PubMed 10858843Ghio M, Contini P, Negrini S, Mazzei C, Zocchi MR, Poggi A. Down regulation of human natural killer cell-mediated cytolysis induced by blood transfusion: role of transforming growth factor-beta(1), soluble Fas ligand, and soluble Class I human leukocyte antigen. Transfusion. 2011 Jul;51(7):1567-73. doi: 10.1111/j.1537-2995.2010.03000.x. Epub 2011 Jan 7.
PubMed 21214580Leal-Noval SR, Munoz-Gomez M, Arellano V, Adsuar A, Jimenez-Sanchez M, Corcia Y, Leal M. Influence of red blood cell transfusion on CD4+ T-helper cells immune response in patients undergoing cardiac surgery. J Surg Res. 2010 Nov;164(1):43-9. doi: 10.1016/j.jss.2009.03.010. Epub 2009 Apr 18.
PubMed 19592026Heiss MM, Fasol-Merten K, Allgayer H, Strohlein MA, Tarabichi A, Wallner S, Eissner HI, Jauch KW, Schildberg FW. Influence of autologous blood transfusion on natural killer and lymphokine-activated killer cell activities in cancer surgery. Vox Sang. 1997;73(4):237-45. doi: 10.1046/j.1423-0410.1997.7340237.x.
PubMed 9407641Suksompong S, Tassaneetrithep B, Ariyawatkul T, Sirivanasandha B, Wilartratsami S, Wongsa A, von Bormann B. Allogeneic red cell transfusion and its influence on relevant humoral and cellular immunological parameters: A prospective observational trial. Eur J Anaesthesiol. 2019 Nov;36(11):814-824. doi: 10.1097/EJA.0000000000001027.
PubMed 31157653
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Red Cell Transfusion and Its Influence on Relevant Humoral and Cellular Immunological Parameters
- ClinicalTrials.gov ID
- NCT02140216
- Acronym / sponsor ID
- Si 081/2557 (EC3)
- Conditions
- Incompatible Blood Transfusion, Immune Defect, Surgery
- Keywords
- Blood transfusion, Immune, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Wolf Schleinzer Stiftung zur Wissenschafts- und Bildungsförderung, Germany
- Study start
- May 2014 (actual)
- Primary completion
- 18 Jun 2017 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 16 May 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.
An increasing number of publications have demonstrated that homologous (allogeneic) blood transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood products cannot solve these problems, despite improved quality of red cells; a recent study demonstrated deteriorated outcome of cancer patients with elective colon surgery and transfusion of leukocyte depleted allogeneic blood.
Detailed description
All patients undergo the identical anesthesiological procedure, including premedication, general anesthesia with endotracheal intubation, monitoring and postoperative pain therapy and mobilization.Surgery is performed by the identical team performing a standardized technique.
Transfusion regimen The 'trigger' for homologous red cell transfusion intra- and postoperatively is the actual hematocrit concentration. Transfusion depends on discretion of the treating physicians. Number of units transfused, amount of blood loss, time, reasoning and decision maker are recorded.
Blood samples Within the kind of surgical procedures chosen for this study the chance of red cell transfusion is about 60 - 70%. In terms of figures 10 non-transfused cases could be gained within 40 cases in total. However, transfusion or non-transfusion does not happen in a row. We expect the total number of patients with blood withdrawal to be between 50 and 60. Additionally withdrawn samples currently not used for analysis will stored for further studies.
The purpose to include non-transfused otherwise fully comparable patients is to distinguish between trauma (operation) and transfusion and their influence on immune modulation. Within the studies about blood transfusion and immune modulation only some few made this differentiation. In patients with colorectal cancer surgery randomized groups with autologous predonation and patients with allogeneic transfusion only have been compared. However, within the latter (allogeneic) group of 27 patients only 13 had to be transfused, thus creating a non-transfusion group of 14 patients. These 14 non-transfused patients remained within the study being compared with autologous and allogeneic transfused patients. Operative trauma and allogeneic transfusion both increased the secretion of several cytokines including tumor necrosis factor (TNF) alpha and Interleukin-10; this effect was less pronounced in patients with autologous- and without any transfusion. Another group studied forty three orthopedic patients with total knee- or hip-arthroplasty, initially to compare autologous to allogeneic red cell transfusion. They had to change their protocol due to the small number of allogeneic transfusions (8 of 43). Including perioperatively transfused patients only (n = 37) they found an increase in immune regulatory cytokine Interleukin (IL)-10 after red cell transfusion, which was most pronounced 7 days after surgery, whereas there was only a mild increase in non- or autologous transfused patients. Unfortunately they did not differentiate between autologous-and non-transfused patients. Thus their data could not reveal the effect of surgery itself on the analyzed parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day 0 blood transfusion | – | Biological: Day 0 blood transfusionPatients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion. |
| Day 1 or 2 blood transfusion | – | Biological: Day 1 or 2 blood transfusionPatients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery. |
| No blood transfusion | – | Biological: No blood transfusionPatients undergoing elective spine surgery receiving no blood transfusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective spine surgery/
Key inclusion criteria (3 listed)
- Patients undergoing elective spine surgery
- American Society of Anesthesiologist Risk score classification (ASA) I-III
- Hemoglobin > 9 gm/dL
Key exclusion criteria (2 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, general or local infection (site of surgery), coagulation disorders, rheumatoid arthritis.
- Patients who have one of the following drugs; aspirin, methotrexate, cyclosporin, qualaquin
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 |
|---|---|---|
| No blood transfusionNo blood transfusion | Biological | No blood transfusion |
| Day 0 blood transfusionPatients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion. | Biological | Day 0 blood transfusion |
| Day 1 or 2 blood transfusionPatients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery. | Biological | Day 1 or 2 blood transfusion |
Primary outcome
Macrophage inflammatory protein 1 alpha (MIP-1a)
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
macrophage inflammatoryprotein 1 beta (MIP-1b)
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
platelet-derived growth factor-BB
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
RANTES
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
tumour TNF alpha
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
VEGF
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
Ferritin
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
Fibrinogen
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
procalcitonin
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
interleukin
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
basic fibroblast growth factor (B-FGF)
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
eotaxin (monocyte chemotactic proteins)
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
G-CSF
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
GM-CSF
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
IFN-alpha
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
IP-10
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
MCP-1
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
MCAF
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
serum amyloid A
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
tissue plasminogen activator
Time frame: 5 days
Blood sample on preoperative, postoperative day 1, 3, 5
Postoperative non-surgical complications
Time frame: 30 days
Infection, thrombosis, pulmonary affection
15 secondary outcomes
CD2 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD3 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD4 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 25 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 30 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 19 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 20 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 138 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 56 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CD 303 Cellular immunologic parameter (non-radioisotope),
Time frame: 5 days
CLT cytotoxicity (non-radioisotope),
Time frame: 5 days
CD 304
Time frame: 5 days
NK cytotoxicity
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 18679112Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008 Sep;36(9):2667-74. doi: 10.1097/CCM.0b013e3181844677.
- Background: PubMed 10858843von Bormann B, Wirtz S, Weiler J, von Bormann C, Trobisch H. [Quality of whole blood as a result of storage and preparation (inline-leukocyte depletion). Evidence for autologous predeposit]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2000 May;35(5):326-32. doi: 10.1055/s-2000-323. German.
- Background: PubMed 21214580Ghio M, Contini P, Negrini S, Mazzei C, Zocchi MR, Poggi A. Down regulation of human natural killer cell-mediated cytolysis induced by blood transfusion: role of transforming growth factor-beta(1), soluble Fas ligand, and soluble Class I human leukocyte antigen. Transfusion. 2011 Jul;51(7):1567-73. doi: 10.1111/j.1537-2995.2010.03000.x. Epub 2011 Jan 7.
- Background: PubMed 19592026Leal-Noval SR, Munoz-Gomez M, Arellano V, Adsuar A, Jimenez-Sanchez M, Corcia Y, Leal M. Influence of red blood cell transfusion on CD4+ T-helper cells immune response in patients undergoing cardiac surgery. J Surg Res. 2010 Nov;164(1):43-9. doi: 10.1016/j.jss.2009.03.010. Epub 2009 Apr 18.
- Background: PubMed 9407641Heiss MM, Fasol-Merten K, Allgayer H, Strohlein MA, Tarabichi A, Wallner S, Eissner HI, Jauch KW, Schildberg FW. Influence of autologous blood transfusion on natural killer and lymphokine-activated killer cell activities in cancer surgery. Vox Sang. 1997;73(4):237-45. doi: 10.1046/j.1423-0410.1997.7340237.x.
- Derived from this study: PubMed 31157653Suksompong S, Tassaneetrithep B, Ariyawatkul T, Sirivanasandha B, Wilartratsami S, Wongsa A, von Bormann B. Allogeneic red cell transfusion and its influence on relevant humoral and cellular immunological parameters: A prospective observational trial. Eur J Anaesthesiol. 2019 Nov;36(11):814-824. doi: 10.1097/EJA.0000000000001027.
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
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 Incompatible Blood Transfusion and Immune Defect, 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 2 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: finished, as of the sponsor's last update on 8 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Macrophage inflammatory protein 1 alpha (MIP-1a) (time frame: 5 days). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140216, which also lists 6 linked publications.
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 8 Sep 2021.