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NCT03037515 · ClinicalTrials.gov registry record · Phase 4
Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery
A Phase 4 study of Blood Loss, Surgical and Blood Loss Anemia, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT03037515: Completed Phase 4 study of Blood Loss, Surgical and Blood Loss Anemia, sponsored by Henry Ford Health System.
NCT03037515 is a Phase 4 study of Blood Loss, Surgical and Blood Loss Anemia that has completed, run by Henry Ford Health System. The registered enrollment target is 83 participants, below the 122-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03037515, a Phase 4 study of Blood Loss, Surgical and Blood Loss Anemia, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.
Primary Outcome
For males: BV = 0.3669\*(Height in meters)\^3 + 0.03219\*(Weight in kilograms) + 0.6041 For females: BV = 0.3561\*(Height in meters)\^3 + 0.03308\*(Weight in kilograms) + 0.1833 Hbloss = BV\*(Hbi-Hbe )\*0.001 + Hbt Blood loss = 1000\*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
Conditions Studied
Interventions
- DRUG Tranexamic Acid
Study Locations (1)
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2018-07-16 |
| Phase | Phase 4 |
What the finished NCT03037515 record still lists
NCT03037515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 122-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Blood Loss, Surgical appearing as the primary indexed condition, and to 1 intervention - of which Tranexamic Acid is the first listed.
NCT03037515 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03037515 about?
NCT03037515 is a clinical study titled "Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery". The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tra...
What is the current status of trial NCT03037515?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 83 participants. The study started on 2017-02-15. Estimated completion is 2018-07-16.
What conditions does trial NCT03037515 study?
This clinical trial studies the following conditions: Blood Loss, Surgical, Blood Loss Anemia.
What interventions are being tested in trial NCT03037515?
The interventions under investigation include: Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT03037515?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03037515 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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