Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04797156 · ClinicalTrials.gov registry record · Early Phase 1
Combined IV and Topical TXA in Major Spine Surgery
A Early Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 65
- Enrollment target
NCT04797156: Completed Early Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04797156 is a Early Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 65 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797156, a Early Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.
Primary Outcome
The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.
Interventions
- DRUG Normal saline
- DRUG High Dose Tranexamic acid
- DRUG Low Dose Tranexamic acid
- DRUG Tranexamic acid Topical
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-03-03 |
| Est. Completion | 2024-08-15 |
| Phase | Early Phase 1 |
What the finished NCT04797156 record still lists
NCT04797156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 4 interventions - of which Normal saline is the first listed.
NCT04797156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04797156 about?
NCT04797156 is a clinical study titled "Combined IV and Topical TXA in Major Spine Surgery". This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative eval...
What is the current status of trial NCT04797156?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 65 participants. The study started on 2021-03-03. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04797156?
The interventions under investigation include: Normal saline (DRUG), High Dose Tranexamic acid (DRUG), Low Dose Tranexamic acid (DRUG), Tranexamic acid Topical (DRUG).
Who is sponsoring clinical trial NCT04797156?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04797156's enrollment target sits among peer trials
65 372nd of 2000 higher than 1,625 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI