NCT02140216

Brief 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 patients with elective colon surgery and transfusion of leukocyte depleted allogeneic blood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

3.1 years

First QC Date

May 5, 2014

Last Update Submit

August 31, 2021

Conditions

Incompatible Blood TransfusionImmune DefectSurgery

Keywords

Blood transfusionImmuneSurgery

Outcome Measures

Primary Outcomes (21)

  • Macrophage inflammatory protein 1 alpha (MIP-1a)

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • macrophage inflammatoryprotein 1 beta (MIP-1b)

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • platelet-derived growth factor-BB

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • RANTES

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • tumour TNF alpha

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • VEGF

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • Ferritin

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • Fibrinogen

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • procalcitonin

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • interleukin

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • basic fibroblast growth factor (B-FGF)

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • eotaxin (monocyte chemotactic proteins)

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • G-CSF

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • GM-CSF

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • IFN-alpha

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • IP-10

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • MCP-1

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • MCAF

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • serum amyloid A

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • tissue plasminogen activator

    Blood sample on preoperative, postoperative day 1, 3, 5

    5 days

  • Postoperative non-surgical complications

    Infection, thrombosis, pulmonary affection

    30 days

Secondary Outcomes (15)

  • CD2 Cellular immunologic parameter (non-radioisotope),

    5 days

  • CD3 Cellular immunologic parameter (non-radioisotope),

    5 days

  • CD4 Cellular immunologic parameter (non-radioisotope),

    5 days

  • CD 8 Cellular immunologic parameter (non-radioisotope),

    5 days

  • CD 8 Cellular immunologic parameter (non-radioisotope),

    5 days

  • +10 more secondary outcomes

Study Arms (3)

Day 0 blood transfusion

Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.

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.

Biological: Day 1 or 2 blood transfusion

No blood transfusion

Patients undergoing elective spine surgery receiving no blood transfusion.

Biological: No blood transfusion

Interventions

No blood transfusionBIOLOGICAL

No blood transfusion

No blood transfusion
Day 0 blood transfusionBIOLOGICAL

Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.

Day 0 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.

Day 1 or 2 blood transfusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective spine surgery/

You may qualify if:

  • Patients undergoing elective spine surgery
  • American Society of Anesthesiologist Risk score classification (ASA) I-III
  • Hemoglobin \> 9 gm/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 18679112BACKGROUND

  • von 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.

    PMID: 10858843BACKGROUND

  • Ghio 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.

    PMID: 21214580BACKGROUND

  • Leal-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.

    PMID: 19592026BACKGROUND

  • Heiss 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.

    PMID: 9407641BACKGROUND

  • Suksompong 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.

    PMID: 31157653DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Sirilak Suksompong, MD

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 16, 2014

Study Start

May 1, 2014

Primary Completion

June 18, 2017

Study Completion

April 10, 2018

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations

TH(1)