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NCT03849443 · ClinicalTrials.gov registry record · Early Phase 1
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
A Early Phase 1 study of Open Posterior Thoracolumbar Spinal Fusion Procedure, sponsored by Rush University Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 604
- Enrollment target
- 1
- Study location
NCT03849443 is a Early Phase 1 study of Open Posterior Thoracolumbar Spinal Fusion Procedure that is actively recruiting participants, run by Rush University Medical Center. The registered enrollment target is 604 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03849443, a Early Phase 1 study of Open Posterior Thoracolumbar Spinal Fusion Procedure, is actively recruiting participants, sponsored by Rush University Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 604 participants
- Enrollment target
- 1
- Study location
Study Summary
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.
Conditions Studied
Interventions
- DRUG Tranexamic Acid Injectable Product (1000 mg intravenous bolus)
- DRUG Vitamin C 250 MG Oral Tablet
- DRUG Tranexamic Acid 650Mg Tablet
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 604 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2027-01-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03849443
The ClinicalTrials.gov registry entry for NCT03849443 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 604 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Open Posterior Thoracolumbar Spinal Fusion Procedure appearing as the primary indexed condition, and to 3 interventions - of which Tranexamic Acid Injectable Product (1000 mg intravenous bolus) is the first listed.
NCT03849443 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03849443 about?
NCT03849443 is a clinical study titled "Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery". As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intraven...
What is the current status of trial NCT03849443?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 604 participants. The study started on 2019-08-26. Estimated completion is 2027-01-01.
What conditions does trial NCT03849443 study?
This clinical trial studies the following conditions: Open Posterior Thoracolumbar Spinal Fusion Procedure.
What interventions are being tested in trial NCT03849443?
The interventions under investigation include: Tranexamic Acid Injectable Product (1000 mg intravenous bolus) (DRUG), Vitamin C 250 MG Oral Tablet (DRUG), Tranexamic Acid 650Mg Tablet (DRUG).
Who is sponsoring clinical trial NCT03849443?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03849443 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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