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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04797156
The ClinicalTrials.gov registry entry for NCT04797156 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Normal saline is the first listed.
NCT04797156 reports 0 study locations.
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.
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