Pharmacological Action Clinical Trial
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.
Verified date | October 2018 |
Source | Sygehus Lillebaelt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | August 16, 2016 |
Est. primary completion date | August 16, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Spine Center of Southern Denmark | Middelfart |
Lead Sponsor | Collaborator |
---|---|
Karen Hoejmark Hansen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative time | Defined as the time in minutes from incision to closure (last stitch) | Intraoperative (The time in minutes from incision to closure (last stitch) was measured) | |
Secondary | Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T. | 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. | Surgical drain volume was estimated visually at two and 18 hours post-operatively. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06040853 -
Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?
|
Phase 4 | |
Not yet recruiting |
NCT05553496 -
Assessment of Rituximab Therapeutic Response Versus Conventional Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT05534802 -
Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass
|
N/A | |
Recruiting |
NCT04190537 -
PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated With Midazolam
|
||
Completed |
NCT03522532 -
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
|
N/A | |
Completed |
NCT03119454 -
"Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice
|
N/A | |
Unknown status |
NCT01614353 -
Medication-taking Preferences & Practices of Patients With Chronic Conditions
|
N/A | |
Recruiting |
NCT03352622 -
Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
|
N/A | |
Recruiting |
NCT06288841 -
Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study
|
N/A | |
Not yet recruiting |
NCT04320277 -
Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.
|
Phase 2/Phase 3 | |
Completed |
NCT03359590 -
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
|
Phase 2 | |
Completed |
NCT05591105 -
Morphine Consumption in the Obese Patients
|
||
Not yet recruiting |
NCT03904303 -
Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep
|
Phase 1 | |
Not yet recruiting |
NCT05453045 -
Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva
|
N/A | |
Completed |
NCT05428683 -
Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery
|
N/A | |
Enrolling by invitation |
NCT02985281 -
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients
|
Phase 2/Phase 3 | |
Recruiting |
NCT06222710 -
Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy
|
N/A | |
Not yet recruiting |
NCT03953287 -
Pharmacokinetic Study of Paracetamol.
|
Phase 1 | |
Recruiting |
NCT03622047 -
Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
|
N/A | |
Active, not recruiting |
NCT06324370 -
Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)
|
N/A |