Trial · NCT03528564
Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia
NCT03528564, Phase 2, Terminated, Unity Health Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia. Trials, record NCT03528564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03528564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia
- NCT number
- NCT03528564
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Unity Health Toronto
- Conditions
- Anemia, Iron Deficiency, Anemia of Chronic Disease, Hip Arthropathy, Knee Arthropathy
- Interventions
- Iron sucrose, Epoetin Alfa, Placebo
- First posted
- 2018-05-18
- Last updated
- 2021-06-18
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vanguard Phase (Initial 12 patients): Feasibility of using Erythropoietin + Intravenous Iron to Treat Preoperative Iron Restrictive Anemia | 18 weeks from randomization | The primary outcome of the vanguard phase is to determine the feasibility of using erythropoietin + intravenous iron to treat preoperative iron restrictive anemia. Feasibility will be measured according to subject enrollment rates, with adherence to the treatment schedule of \>80%. |
| Primary | Full Study: Preoperative Hemoglobin Concentration | 6 weeks from randomization | The primary outcome of the full study is preoperative hemoglobin concentration, as measured on the day of surgery in patients with iron restricted anemia. |
| Secondary | Post-Treatment Hemoglobin Concentration | 12 weeks from randomization | Change in post-treatment hemoglobin concentration from baseline |
| Secondary | Change in Hemoglobin Concentration from Initiation of Treatment | 6 weeks from randomization | Rate of hemoglobin change from initiation of treatment to final preoperative hemoglobin |
| Secondary | Postoperative Hemoglobin Concentration | 0 weeks from surgery and 12 weeks from surgery | Hemoglobin concentration on postoperative day 2 (prior to hospital discharge); and 4-6 weeks after surgery |
| Secondary | Red Blood Cell Transfusions | 6 weeks from surgery | Rate of RBC transfusion and number of units transfused during surgery and up to 6 weeks postoperatively |
| Secondary | Deep Vein Thrombosis | 12 weeks from surgery | Incidence of DVT up to 12 weeks postoperatively |
| Secondary | Composite of Morbidity | 3 months from surgery | Incidence of a composite clinical outcome including death, stroke, myocardial infarction, pulmonary embolism, infection, acute kidney injury, and deep vein thrombosis from treatment to up to 3 months post surgery |
| Secondary | Surgical Wound Infection | 6 weeks from surgery | Incidence of superficial and deep wound infection from treatment to 4-6 weeks post surgery |
| Secondary | Assessment of Iron Status | 6 weeks from surgery | Hematological outcomes for treatment efficacy including: Hb, ferritin, hepcidin, and transferrin saturation (TSAT) pre-operatively and 4-6 weeks postoperatively |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03528564
GET https://conductscience.org/api/trials/v1/NCT03528564/registered