Reducing Blood Loss Using Tisseel in TKA

NCT03310060 | Unknown Phase 4

• 1 other identifier: 201700271A3
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of the topical hemostatic agents in patients receiving primary TKA procedures. The investigators will also observe if there is increased risk of blood transfusion rate by using topical hemostatic agents or not.

Conditions

Total Blood Loss

Outcome Measures

Primary Outcomes (1)

• Total blood loss after operation

  Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x \[change in Hb level / preoperative Hb level\])x1000+volume transfused

  from the operation to the postoperative day 3

Secondary Outcomes (4)

• Incidence of any thrombotic events

  within 30 days of the operation

• Incidence of wound infection after surgery

  within 30 days of the operation

• Blood transfusion requirement

  from the operation to postoperative day 14

• Calculated blood loss from drainage

  from the operation to the postoperative day 2 until drainage removal

Study Arms (2)

Tisseel combined Tranexamic acid

ACTIVE COMPARATOR

Drug: Tisseel® Applied on potential bleeding sites. The entire content was 4 mL. Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery

Drug: Tisseel; Drug: Tranexamic Acid

Tranexamic acid

PLACEBO COMPARATOR

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg before surgical incision and 3 hours after surgery

Drug: Tranexamic Acid

Interventions

Tisseel DRUG

Tisseel® (Fibrin Sealant, 4ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 4 mL vial containing the active product was used

Also known as: Fibrin Sealant

Tisseel combined Tranexamic acid

Tranexamic Acid DRUG

Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery

Also known as: Transamin

Tisseel combined Tranexamic acid; Tranexamic acid

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• After cardiologist or neurologist's evaluation, patients who was classified as low-risk of perioperative risk with advanced knee osteoarthritis who was failure of medical treatment or rehabilitation and within age limit

You may not qualify if:

• Preoperative Hemoglobin ≦12 g/dl History of infection or intraarticular fracture of the affective knee, Renal function deficiency (GFR \< 30 ml/min/1.73m2), Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Exsanguination

Interventions

Fibrin Tissue Adhesive; Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 16, 2017
• Study Start: November 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 16, 2017

Record last verified: 2017-09