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NCT03528057
Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy
NA trial testing Hemostat in Robotic-Assisted Laparoscopic Partial Nephrectomy. Withdrawn.
1 May 2019
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 18 April 2018 |
| Primary completion | 1 May 2019 |
| Estimated completion | 1 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hemostat
Conditions studied
- Robotic-Assisted Laparoscopic Partial Nephrectomy — all drugs for Robotic-Assisted Laparoscopic Partial Nephrectomy →
- Hemostatic Agents — all drugs for Hemostatic Agents →
- Renal Malignant Tumor — all drugs for Renal Malignant Tumor →
Sponsor
Northwestern University
Who can join
Adults 18 to 89, any sex, with Robotic-Assisted Laparoscopic Partial Nephrectomy or Hemostatic Agents. 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.
-
Absolute change in hemoglobin
Time frame: Morning after surgery
This will be measured as the difference between the hemoglobin obtained postoperatively (measured at approximately 4 am in the morning after surgery) and the hemoglobin obtained preoperatively in the holding area on the day of surgery.
Sponsor's own description
The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03528057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03528057 (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 Northwestern University
- Last refreshed: 2 July 2019
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/NCT03528057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing