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NCT01888003: PAMP
The Benefits of a Preoperative Anemia Management Program
NA trial testing Iron sucrose in Anemia, Iron-Deficiency in 51 participants. Terminated before completion.
1 January 2015
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 April 2013 |
| Primary completion | 1 January 2015 |
| Estimated completion | 1 January 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Iron sucrose — full drug profile →
- Epoetin Alfa (EPOETIN ALFA) — full drug profile →
- Blood Transfusion — full drug profile →
Conditions studied
- Anemia, Iron-Deficiency — all drugs for Anemia, Iron-Deficiency →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 19 to 80, any sex, with Anemia, Iron-Deficiency. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
Time frame: During surgery (less than 1 day)
The number of subjects who had blood transfusions (at least 1) during surgery -
Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
Time frame: post surgery through discharge, an average of 2 days
Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital -
Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery
Time frame: post hospital discharge through 90 days after surgery
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
Sponsor's own description
The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneous doses of a drug given before surgery, which stimulates the natural production of red blood cells (a so-called erythropoietic stimulating agent \[ESA\]) along with intravenous iron, in reducing the need for blood transfusions (donated by someone other than the patient) during and after adult total hip arthroplasty (hip replacement surgery). The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery will also be examined. A cost-effectiveness analysis will be performed to compare the cost of these commercially available, FDA-approved medications versus the cost of transfused blood
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01888003
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Iron sucrose
Trials testing the same drug.
- NCT06487299 — Iron Administration Via Colonic TET Combined With WMT for ID · Phase 2 · not yet recruiting
- NCT06596161 — Iron Therpay and Fatigue in Women of Reprodcutive Age · NA · completed
- NCT05251493 — Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy · Phase 3 · recruiting
- NCT03528564 — Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia · Phase 2 · terminated
- NCT03917394 — Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty · unknown
Other recruiting trials for Anemia, Iron-Deficiency
Currently open trials in the same condition.
- NCT06810440 — Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention · NA · recruiting
- NCT06637137 — Patient Blood Management in Patients Scheduled for Cardiac Surgery · recruiting
Other University of Alabama at Birmingham trials
Trials by the same sponsor.
- NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
- NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
- NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
- NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
- NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01888003 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 26 May 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01888003.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing