NCT01027546

Brief Summary

The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2009

Completed
Last Updated

December 8, 2009

Status Verified

May 1, 2008

Enrollment Period

1.3 years

First QC Date

December 7, 2009

Last Update Submit

December 7, 2009

Conditions

Cervical Myelopathy

Keywords

perioperative blood loss, spinal surgery

Outcome Measures

Primary Outcomes (1)

  • perioperative blood loss

    during and after surgery

Study Arms (1)

placebo, tranexamic acid

PLACEBO COMPARATOR
Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

Administer 15 mg/kg body weight of tranexamic Acid mixed in 100 mL saline intravenously over 15 min before the skin incision

placebo, tranexamic acid

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.

You may not qualify if:

  • Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 8, 2009

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 8, 2009

Record last verified: 2008-05