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NCT04089865 · ClinicalTrials.gov registry record · Phase 4
Oral Versus Intravenous Tranexamic Acid
A Phase 4 study of Blood Loss and Blood Transfusion, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT04089865: Completed Phase 4 study of Blood Loss and Blood Transfusion, sponsored by Hospital for Special Surgery, New York.
NCT04089865 is a Phase 4 study of Blood Loss and Blood Transfusion that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 400 participants, above the 143-participant average among 9 other Blood Loss trials with a reported enrollment target (180% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089865, a Phase 4 study of Blood Loss and Blood Transfusion, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are: Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing? Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing? Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
Primary Outcome
Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time p
Conditions Studied
Interventions
- DRUG Tranexamic Acid
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2021-11-10 |
| Phase | Phase 4 |
What the finished NCT04089865 record still lists
NCT04089865 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 143-participant average among 9 other Blood Loss trials with a reported enrollment target (180% higher).
The record links to 2 conditions, with Blood Loss appearing as the primary indexed condition, and to 1 intervention - of which Tranexamic Acid is the first listed.
NCT04089865 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04089865 about?
NCT04089865 is a clinical study titled "Oral Versus Intravenous Tranexamic Acid". The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are: Does oral TXA dosing i...
What is the current status of trial NCT04089865?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2019-09-17. Estimated completion is 2021-11-10.
What conditions does trial NCT04089865 study?
This clinical trial studies the following conditions: Blood Loss, Blood Transfusion.
What interventions are being tested in trial NCT04089865?
The interventions under investigation include: Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT04089865?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04089865 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04089865's enrollment target sits among peer trials
400 1st of 9 higher than 9 of 9 other Blood Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Blood Loss 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.
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