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NCT02063035 · ClinicalTrials.gov registry record · Phase 4
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT02063035: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02063035 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02063035, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-04-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02063035
The ClinicalTrials.gov registry entry for NCT02063035 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02063035 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02063035 about?
NCT02063035 is a clinical study titled "Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery". Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. ...
What is the current status of trial NCT02063035?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2012-08. Estimated completion is 2015-04-22.
What interventions are being tested in trial NCT02063035?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT02063035?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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