Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 419 for:    TRANEXAMIC ACID

Tranexamic Acid in Total Hip Arthroplasty. (PORTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252497
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.

Condition or disease Intervention/treatment Phase
Hip Arthroplasty Drug: Active comparator : Tranexamic Acid (Exacyl) Drug: Placebo comparator : physiologic serum Phase 4

Detailed Description:
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.
Study Start Date : April 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid
  • 1g Intra Venous just before surgery
  • Then infusion of 1g of Exacyl over eight hours.
Drug: Active comparator : Tranexamic Acid (Exacyl)
  • 1g Exacyl Intra Venous, just before surgery
  • Then infusion of 1g of Exacyl over eight hours .

Placebo Comparator: Physiologic serum
  • 1g Intra Venous, just before surgery
  • Then infusion of 1g of physiologic serum over eight hours.
Drug: Placebo comparator : physiologic serum
  • 1g Intra Venous just before surgery
  • Then infusion of 1g of physiologic serum over eight hours




Primary Outcome Measures :
  1. Calculated volume of blood losses in the peroperative period. [ Time Frame: between the beginning of surgery and the fifth day ]
    It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.


Secondary Outcome Measures :
  1. the patients' percentage that will receive the transfusion of at least one allogenic globular sediment [ Time Frame: between D1 (day of surgery) and D5 (the fourth postoperative day) ]
    the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.

  2. incidence of symptomatic thrombotic events and death [ Time Frame: in 6 weeks ]
    combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death

  3. tranexamic acid pharmacokinetic analyses [ Time Frame: from the beginning of surgery up to 8 hours ]
    non linear mixt effect model



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months)
  • Consent of the patient or a family member or the support person.

Exclusion Criteria:

  • Contraindication to tranexamic acid.
  • Contraindication to apixaban.
  • Pregnancy.
  • Patient receiving a curative anticoagulating treatment in the preoperative period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252497


Locations
Layout table for location information
France
CHU de Saint-Etienne
SAINT-ETIENNE cedex 2, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Paul ZUFFEREY, MD CHU SAINT-ETIENNE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02252497     History of Changes
Other Study ID Numbers: 1308015
2013-000791-15 ( EudraCT Number )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
hip arthroplasty
Tranexamic acid
randomized control trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants