Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

NCT ID: NCT01643135

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

Brief Summary

Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).

Detailed Description

78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.

Conditions

Bleeding

Keywords

tranexamic acid; bleeding; blood transfusion; spine surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tranexamic acid

Tranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose.

Group Type: ACTIVE_COMPARATOR

tranexamic acid

Intervention Type: DRUG

Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)

0.9% NaCl

0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose

Group Type: PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type: DRUG

0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid

Interventions

tranexamic acid

Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)

Intervention Type: DRUG

0.9% NaCl

0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid

Intervention Type: DRUG

Other Intervention Names

transamine (Daiichi-Sankyo, Japan); NSS

Eligibility Criteria

Inclusion Criteria

• has laminectomy with instrumentation or equal or more than 3 levels laminectomy
• age 18-65 years
• ASA 1-3
• elective operation

Exclusion Criteria

• allergy to tranexamic acid
• anemia (Hb<12 g/dl in female or Hb<13 g/dl in male)
• history of CVT, IHD, PE, strokes
• liver disease
• chronic kidney disease with creatinie>2.0 mg/dl
• receive anticoagulant or coagulopathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Manee Raksakietisak

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manee Raksakietisak, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Manee Raksakietisak

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

si248/2012

Identifier Type: -

Identifier Source: org_study_id