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Completed

NCT Number: NCT01643135

Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manee Raksakietisak

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: transamine (Daiichi-Sankyo, Japan)

0.9% NaCl

Drug

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

Other names: NSS

Primary outcomes

  1. perioperative blood loss

    Time frame: 24 hours

    Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage

Secondary outcomes

  1. perioperative blood transfusion

    Time frame: 24 hours

    When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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