The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.

PHASE4CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 19, 2015

Primary Completion Date

August 16, 2016

Study Completion Date

August 16, 2016

Conditions
Pharmacological Action
Interventions
DRUG

Tranexamic Acid

patients with ASA(American Society of Anesthesiologists grades) 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).

DRUG

Sodium Chloride 0,9%

Sodium Chloride 0,9%

Trial Locations (1)

5500

Spine Center of Southern Denmark, Middelfart

All Listed Sponsors
lead

Mikkel Østerheden Andersen

OTHER

NCT03714360 - The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery. | Biotech Hunter | Biotech Hunter