Anemia Clinical Trial
Official title:
The Change in RetHe - Levels Perioperatively in a Cohort of Colorectal Surgery Patient: it's Role in Perioperative Hemoglobin Optimization
NCT number | NCT03500497 |
Other study ID # | RACEmumc |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 25, 2017 |
Est. completion date | January 2, 2019 |
Verified date | January 2019 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
During a period of a year, reticulocyte hemoglobin content (RetHe) measurements (Sysmex) are
done out of blood samples taken on several occasions during normal patient care:
1. preoperatively at the surgical or anesthetic outpatient visit
2. on admission or pre- induction of anesthesia
3. postoperatively at the postanesthetic care unit
4. on day 3 postoperatively
5. on day 5 postoperatively
Additionally a Quality of Life (QoL) questionnaire will be taken from the participants before
surgery and 30 days after surgery to evaluate the course of QoL perioperatively.
Status | Completed |
Enrollment | 164 |
Est. completion date | January 2, 2019 |
Est. primary completion date | November 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients (= 18 years) scheduled for colorectal surgical operations (laparoscopic and open procedures) Exclusion Criteria: - emergency surgery - minors and incapacitated |
Country | Name | City | State |
---|---|---|---|
Netherlands | MUMC | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Aapro M, Österborg A, Gascón P, Ludwig H, Beguin Y. Prevalence and management of cancer-related anaemia, iron deficiency and the specific role of i.v. iron. Ann Oncol. 2012 Aug;23(8):1954-62. doi: 10.1093/annonc/mds112. Epub 2012 May 9. Review. — View Citation
Archer NM, Brugnara C. Diagnosis of iron-deficient states. Crit Rev Clin Lab Sci. 2015;52(5):256-72. doi: 10.3109/10408363.2015.1038744. Epub 2015 Aug 14. Review. — View Citation
Beale AL, Penney MD, Allison MC. The prevalence of iron deficiency among patients presenting with colorectal cancer. Colorectal Dis. 2005 Jul;7(4):398-402. — View Citation
Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918. Review. — View Citation
Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646. — View Citation
Gozzard D. When is high-dose intravenous iron repletion needed? Assessing new treatment options. Drug Des Devel Ther. 2011 Jan 20;5:51-60. doi: 10.2147/DDDT.S15817. Review. — View Citation
Herrera-deGuise C, Casellas F, Robles V, Navarro E, Borruel N. Iron Deficiency in the Absence of Anemia Impairs the Perception of Health-Related Quality of Life of Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jun;22(6):1450-5. doi: 10.1097/MIB.0000000000000768. — View Citation
Jans Ø, Bandholm T, Kurbegovic S, Solgaard S, Kjaersgaard-Andersen P, Johansson PI, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Postoperative anemia and early functional outcomes after fast-track hip arthroplasty: a prospective cohort study. Transfusion. 2016 Apr;56(4):917-25. doi: 10.1111/trf.13508. Epub 2016 Mar 4. — View Citation
Kanuri G, Sawhney R, Varghese J, Britto M, Shet A. Iron Deficiency Anemia Coexists with Cancer Related Anemia and Adversely Impacts Quality of Life. PLoS One. 2016 Sep 28;11(9):e0163817. doi: 10.1371/journal.pone.0163817. eCollection 2016. — View Citation
Keeler BD, Mishra A, Stavrou CL, Beeby S, Simpson JA, Acheson AG. A cohort investigation of anaemia, treatment and the use of allogeneic blood transfusion in colorectal cancer surgery. Ann Med Surg (Lond). 2015 Dec 22;6:6-11. doi: 10.1016/j.amsu.2015.12.052. eCollection 2016 Mar. — View Citation
Mast AE, Blinder MA, Dietzen DJ. Reticulocyte hemoglobin content. Am J Hematol. 2008 Apr;83(4):307-10. — View Citation
Mouysset JL, Freier B, van den Bosch J, Levaché CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016. — View Citation
Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5. — View Citation
So-Osman C, Nelissen R, Brand R, Brand A, Stiggelbout AM. Postoperative anemia after joint replacement surgery is not related to quality of life during the first two weeks postoperatively. Transfusion. 2011 Jan;51(1):71-81. doi: 10.1111/j.1537-2995.2010.02784.x. — View Citation
Thomas DW, Hinchliffe RF, Briggs C, Macdougall IC, Littlewood T, Cavill I; British Committee for Standards in Haematology. Guideline for the laboratory diagnosis of functional iron deficiency. Br J Haematol. 2013 Jun;161(5):639-48. doi: 10.1111/bjh.12311. Epub 2013 Apr 10. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of RetHe measurement | To assess the change of RetHe measurement from baseline (preoperative assessment) to different points in time in standard care (i.e. RetHe measurement at day of admission, direct postoperatively and day 3 and 5 postoperatively) | From baseline to 60 days postoperatively | |
Secondary | Relation of RetHe to standard iron status measurements | In case of relevant RetHe aberrations those will be compared to the standard iron status measurements (i.e. transferrin saturation and ferritin) | 1 year | |
Secondary | Perioperative complications | The complications will be scaled according to the Calvien-Dindo classification | Days of admission | |
Secondary | Quality of life measurement preoperatively and 30-days postoperatively | Validated quality of life patient questionnaire (i.e. FACT-An) is asked from the preoperatively and 30-days postoperatively | From baseline to 30-days postoperatively |
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