Recruitment

Recruitment Status
Completed

Inclusion Criterias

Primary total knee replacmeent
Unilateral
Osteoarthritis
Primary total knee replacmeent
Unilateral
Osteoarthritis

Exclusion Criterias

Revision surgery
Pregnant
Donated preoperative autologous blood
...
Revision surgery
Pregnant
Donated preoperative autologous blood
Preoperative hemoglobin <10g/dL
Creatinine > 1.4
Breastfeeding
International Normalized Ratio>1.4
Diagnosis of inflammatory disease
Preoperative hepatic or renal dysfunction
Diagnosis of inflammatory arthritis
Preoperative platelet count of <150,000mm^3
Abnormal Partial Thromboplastin Time
On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)

Summary

Conditions
Osteoarthritis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

Description

This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid i...

This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision. The primary result measurement will be blood drain output from the knee at 24 hours after surgery.

Inclusion Criterias

Primary total knee replacmeent
Unilateral
Osteoarthritis
Primary total knee replacmeent
Unilateral
Osteoarthritis

Exclusion Criterias

Revision surgery
Pregnant
Donated preoperative autologous blood
...
Revision surgery
Pregnant
Donated preoperative autologous blood
Preoperative hemoglobin <10g/dL
Creatinine > 1.4
Breastfeeding
International Normalized Ratio>1.4
Diagnosis of inflammatory disease
Preoperative hepatic or renal dysfunction
Diagnosis of inflammatory arthritis
Preoperative platelet count of <150,000mm^3
Abnormal Partial Thromboplastin Time
On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)

Locations

New York, New York, 10021
Rochester, Minnesota, 55902
New York, New York, 10021
Rochester, Minnesota, 55902

Tracking Information

NCT #
NCT01940523
Collaborators
Mayo Clinic
Investigators
  • Principal Investigator: David Mayman, MD Hospital for Special Surgery, New York
  • David Mayman, MD Hospital for Special Surgery, New York