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NCT03553186 · ClinicalTrials.gov registry record · Phase 3

Tranexamic Acid in Adult Spinal Deformity Surgery

A Phase 3 study of Spinal Deformity and Blood Loss, Surgical, sponsored by Hospital for Special Surgery, New York.

Recruiting
Registry status
Phase 3
Development phase
100
Enrollment target
1
Study location

NCT03553186 is a Phase 3 study of Spinal Deformity and Blood Loss, Surgical that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 100 participants, below the 609-participant average among 7 other Spinal Deformity trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03553186, a Phase 3 study of Spinal Deformity and Blood Loss, Surgical, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.

RECRUITING
Registry status
Phase 3
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.

Interventions

  • DRUG Placebo
  • DRUG Tranexamic Acid 100 MG/ML

Study Locations (1)

New York

  • Hospital for Special Surgery - New York

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2018-07-11
Est. Completion 2026-03
Phase Phase 3

What the Registry Record Tells You About NCT03553186

The ClinicalTrials.gov registry entry for NCT03553186 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 7 other Spinal Deformity trials with a reported enrollment target (84% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Spinal Deformity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03553186 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03553186 about?

NCT03553186 is a clinical study titled "Tranexamic Acid in Adult Spinal Deformity Surgery". Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic age...

What is the current status of trial NCT03553186?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2018-07-11. Estimated completion is 2026-03.

What conditions does trial NCT03553186 study?

This clinical trial studies the following conditions: Spinal Deformity, Blood Loss, Surgical, Degenerative Lumbar Spinal Stenosis.

What interventions are being tested in trial NCT03553186?

The interventions under investigation include: Placebo (DRUG), Tranexamic Acid 100 MG/ML (DRUG).

Who is sponsoring clinical trial NCT03553186?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03553186 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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