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
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.
Study design An explorative, prospective cohort study of patients undergoing colorectal
surgery in the Maastricht University Medical Center (MUMC) with a follow-up time of 30 days
postoperatively.
A quality of life questionnaire (EQ-5D) will be administered on admission and 30 days
postoperatively.
Origin of data Medical file of patients (SAP, PDMS) Database Study data are anonymous
information, which cannot be tracked to the patient according to wet bescherming
persoonsgegevens (WBP) and wet op geneeskundige behandelingsovereenkomst (WGBO). These will
be stored at Castor Electronic Data Capture (EDC), secure online data collection for medical
research), that embraces Good Clinical Practice (GPC) guidelines. For the analysis,
anonymized data will be exported to Statistical Package for the Social Sciences (SPSS).
Preoperative anemia in the colorectal surgical population is a common and independent risk
factor of perioperative morbidity and mortality. The detection, diagnostic and treatment of
anemia are therefore a multidisciplinary obligation in the optimization of patient care.
In the perioperative setting anemia can be divided into three categories:
- Pre-existing anemia prior to surgery (blood loss, chronic and acute inflammatory
response, increased destruction (haemolysis), chemotherapy)
- Anemia caused by the surgical intervention (blood loss, acute inflammatory response,
increased destruction)
- Anemia due to iatrogenic causes (blood sampling, haemodilution)
Adequate diagnostic is needed to determine anemia in the perioperative setting in order to
guide appropriate further therapy.
Preoperative diagnostic approaches have recently been implemented to direct the treatment of
pre-existing anemia with the intention to optimize preoperative hemoglobin levels. Laboratory
evaluation is based on measurements of ferritin, transferrin saturation (TfS), C-reactive
protein (CRP) and renal function to screen for the underlying cause of anemia. One compelling
component of the preoperative augmentation of haemoglobin level is intravenous iron
administration in case of absolute or functional iron deficiency.
Unfortunately, the laboratory diagnostic of iron status is limited due to the interaction of
inflammatory response with the markers (ferritin, TfS). As the main goal of therapy is
haemoglobin optimization it seems appropriate to use erythropoietic parameters to assess the
adequacy of iron therapy. The hemoglobin content of the reticulocyte (RetHe), which describes
the erythropoietic responsiveness to iron therapy at the level of erythrocytes precursors,
has been shown to be a sensitive and rapid marker. Since reticulocytes have a more rapid
turnover in circulation than mature red cells (1-2 vs 120 days), it is hypothesized that the
assessment of RetHe can mirror responsiveness to therapy within the perioperative setting in
a more timely manner. Moreover the course of perioperative RetHe has not been examined and
the aim of this study is to assess the differences in RetHe between the participants and
during their time of admission.
Therefore this parameter could be useful in the perioperative period to further guide
adequate management.
Another aspect that we would like to track is the influence of iron deficiency +/- anemia on
quality of life (QoL) in this patient group. While some studies show a strong relationship
between iron deficiency anemia on QoL in patients with cancer or ischemic bowel disease, the
overall effect in the perioperative setting remains unproven.
In our setting we experience a very variable time frame for preoperative patient optimization
in relation with organizational issues and urgency of surgery. The required time period from
diagnosis to actual operation for elective procedures is nominated to be maximal 3 weeks.
To give all patients the chance to optimize anemia preoperatively or support postoperative
erythropoetic activity, we have determined in a multidisciplinary advisory to use intravenous
iron as soon as possible after diagnosis, including the day of operation.
To our knowledge, RetHe has not been assessed as a progression parameter for iron therapy in
clinical setting within that patient group. Cut off values are validated. Because
reticulocyte parameters change within 24 -48 hours, we chose RetHe rather than hemoglobin
(Hb) as biochemical marker of bone marrow activity.
Clinical practice During a period of a year all participants scheduled for colorectal surgery
will be included. Registration of hematological parameters includes the hemoglobin
concentration, mean cell volume (MCV), mean corpuscular hemoglobin concentration (MCHC) and
RetHe. The iron status is recorded by ferritin and transferrin saturation preoperatively. CRP
and renal function tests are followed to differentiate the cause of anemia and to guide
perioperative management. Interventions, which interact with the hemoglobin level will be
registered. All laboratory investigations are standardized care in our institution. The RetHe
measurement can be retrieved out of the same blood sample used in standard care. Beyond that
also kind and length of operation and postoperative morbidity and mortality are of interest.
Data collection:
A study-specific internet-based case record form will be used to register specific study data
and complications (Castor EDC). Assessment of postoperative complications are scored
according to the Calvien-Dindo classification. All of the study parameters are part of the
routine medical record of surgical patients and can be derived from electronic patient files.
The only hematological diagnostic which are beyond our current standardized care is RetHe,
which can be measured in the same blood sample as taken for Hb measurement. No additional
blood sampling is needed.
The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire will be
administered preoperatively and 30 days postoperatively on paper or digital based on
participant preference. Completed questionnaires on paper will be entered in Castor EDC
manually.
Statistical analysis The prevalence of preoperative anemia and perioperative complications
will be reported as frequencies and percentages, accompanied by a measure of precision.The
variance of RetHe values between participants will be computed. We will plot figures to
explore the average RetHe and Hb values from baseline to postoperatively. Using an
independent t-test, we will test the difference in preoperative RetHe values between anemic
patients and those who are not anemic. Hematological parameters as well as inflammatory
marker and organ function tests will be analyzed in view of iron supplementation.
A cost assessment for the use of intravenous iron, postoperative complications and hospital
stay will be included in the final study analysis.
Patient benefit For the patients who will participate in this current study there are no
direct benefits. Nor is there any harm or even increased burden for them. However, for future
patients results form this study could prove very beneficial in terms of individualized
anemia optimization perioperatively. This has the potential to improve postoperative outcome
and the QoL of the patients.
Data management Data will be handled confidentially. Participants will be given a random
study identification code that is not based on the participants' birth date or initials. One
way coding using ascending numbers will be used. Access to the coding system is only granted
to the investigators. Additionally we will record anonymous participant data, which are
registered routinely throughout hospital admission, for audit purposes to complete our data.
The blood samples of the participants will be managed as it is required for standard patient
care, but in agreement with the participant, they will be stored until the study is
completed, so that additional measurements can be done. As RetHe is not a standardized
parameter in clinical care, its comparison with the current standard assay (ferritin and TfS)
may be warranted as part of this investigation to amplify findings.
The data management system Castor EDC will be used for electronic Case Report Forms (eCRFs)
and storage of the study data. Castor EDC is fully compliant with GPC guidelines on data
safety. After the study, all data will be kept for 15 years for verification purposes.
Publication policy Both positive and negative results of this study will be disclosed
unreservedly through publication in peer-reviewed scientific journals.
Informed consent As the Human Subjects study protocol may be assessed as non-WMO (wet medish
wetenschappelijk onderzoek) research, written informed consent will be gained from the
prospective cohort (see appendix). No historic cohort needs to be analyzed as the study is
merely prospective.
The participants will be first informed about the study when referred for surgery by the
treating doctor. They will receive the patient information sheet and will be given time to
consider their participation. Usually more than a week, but minimally one day for elective
procedures. In case of emergency procedures, informed consent will be asked at the same time
as anesthetic consent. The investigator is responsible for timely information about the study
and the obtainment of consent.
Data, which will be collected, are strictly not identifiable personal information and
collection, storage and analysis will be according to the Code of Conduct (Gedragscode
Gezondheidsonderzoek, article 3).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
Completed |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 | |
Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A |