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

Sponsor

Karen Hoejmark Hansen (Other)

Overall Status

Completed

CT.gov ID

NCT03714360

Collaborator

(none)

250

Enrollment

Location

Arms

9.9

Actual Duration (Months)

25.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Pharmacological Action	Drug: Tranexamic Acid Drug: Sodium Chloride 0,9%	Phase 4

Detailed Description

Study Design: Double-blind, randomized, placebo-controlled, parallel-group study.

Objective: To investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery on operative time, estimated blood loss and complications.

Summary of Background Data: Studies have shown that TXA reduces blood loss during major spine surgery. There are no studies on the effect of TXA in minor lumbar spine surgery on operative time, intraoperative and postoperative blood loss and complications.

Methods: We enrolled patients with ASA grades 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA or history of convulsion were excluded. 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Tranexamic Acid on Duration of Surgery, Bleeding and Complications. A Double Blind, Placebo-controlled, Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.

Actual Study Start Date :

Oct 19, 2015

Actual Primary Completion Date :

Aug 16, 2016

Actual Study Completion Date :

Aug 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TXA tranexamic acid a single dose of 10 mg/kg of TXA, with a maximum dose of 1g. Administered as IV injection and marked as 'project-drug' and amount (mL) in the medical record.	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). Other Names: TXA
Placebo Comparator: Sodium Chloride 0,9% an equivalent volume 0.9 % Sodium Chloride.	Drug: Sodium Chloride 0,9% Sodium Chloride 0,9%

Arm

Intervention/Treatment

Experimental: TXA tranexamic acid

a single dose of 10 mg/kg of TXA, with a maximum dose of 1g. Administered as IV injection and marked as 'project-drug' and amount (mL) in the medical record.

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).

Other Names:

TXA

Placebo Comparator: Sodium Chloride 0,9%

an equivalent volume 0.9 % Sodium Chloride.

Drug: Sodium Chloride 0,9%

Sodium Chloride 0,9%

Outcome Measures

Primary Outcome Measures

Operative time [Intraoperative (The time in minutes from incision to closure (last stitch) was measured)]
Defined as the time in minutes from incision to closure (last stitch)

Secondary Outcome Measures

Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T. [Surgical drain volume was estimated visually at two and 18 hours post-operatively.]
Intra-operative blood loss was estimated by adding the weight (1g=1mL) of swabs and blood in the suction bottle and subtracting all fluids added to the surgical field. Surgical drain volume was estimated visually at two and 18 hours post-operatively. Total volume of peri-operative blood loss was calculated as the volume of intraoperative blood loss plus the post-operative volume measured from the drain output.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients referred to the Centre for Spine Surgery and Research in the Region of Southern Denmark with symptomatic, MRI-verified lumbar spinal stenosis or disc herniations
low risk (American Society of Anesthesiologists, ASA, score 1-2) adult patients scheduled for elective primary decompression or/and discectomy over one to two vertebral levels (without fusion or instrumentation), willing to give informed consent.

Exclusion Criteria:

Not able to understand verbal and/or written Danish ASA score more than 2 Malignant disease Pregnancy Breast feeding

Contraindications to TXA:

Active thromboembolic disease Coagulopathy History of venous or arterial thrombosis Hypersensitivity to the active substance Disseminated intravascular coagulation Severe renal impairment History of convulsions ASA - American Society of Anesthesiologists score, TXA - Tranexamic acid.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spine Center of Southern Denmark	Middelfart		Denmark	5500

Sponsors and Collaborators

Karen Hoejmark Hansen

Investigators

Study Chair: Mikkel Andersen, MD, Sygehus Lillebaelt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karen Hoejmark Hansen, Head of the research secretariat., Sygehus Lillebaelt

ClinicalTrials.gov Identifier:

NCT03714360

Other Study ID Numbers:

S-20150072

First Posted:

Oct 22, 2018

Last Update Posted:

Oct 22, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karen Hoejmark Hansen, Head of the research secretariat., Sygehus Lillebaelt

TXA;decompression; discectomy; operative time; blood loss

Additional relevant MeSH terms:

Tranexamic Acid

Study Results

No Results Posted as of Oct 22, 2018