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Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban (ESPER)

Primary Purpose

Blood Loss After a Total Hip Replacement

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Exacyl®
Placebo of Exacyl®
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss After a Total Hip Replacement focused on measuring Hip replacement, rivaroxaban, exacyl, blood loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years of age
  • Scheduled to undergo elective non-traumatic primary cementless THA
  • Having given written informed consent to participate in the trial
  • Covered by Social Security

Exclusion Criteria:

  • Rapidly destructive arthrosis of the hip
  • History of prior surgery on the operative hip

  • Contraindications to the use of tranexamic acid:

    • Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke)
    • History of venous thromboembolism
    • Severe renal impairment, i.e. with clearance < 30mL/mn
    • Epilepsy or history of convulsions

  • Contraindications to the use of rivaroxaban

    • Severe renal failure (clearance <30ml / min)
    • Cirrhotic patients with Child Pugh B
    • Pregnancy and breastfeeding
  • Cognitive disorder that precludes giving informed consent
  • Refusal to participate in trial
  • Allergy to either of the trial treatments
  • On-going prophylaxis of thrombosis using an agent other than rivaroxaban
  • On-going platelet aggregation inhibitor at a dose exceeding 125 mg daily

Sites / Locations

  • HIA Clermont Tonnerre Brest
  • Polyclinique de Keraudren
  • CHRU Brest
  • CH Morlaix

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: Exacyl®: Standard treatment

Group 2: Exacyl®: Extended treatment

Group 3: Placebo

Arm Description

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11

This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11

Outcomes

Primary Outcome Measures

Total blood loss
Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht

Secondary Outcome Measures

Difference in haemoglobin level (g/dL) between Day-1 and Day+3
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
Surgical revision
Occurrence of venous or arterial thromboembolic events
Local infectious complications
Death due to any cause and death due to cardiovascular cause

Full Information

First Posted
March 13, 2015
Last Updated
January 8, 2018
Sponsor
University Hospital, Brest
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02403596
Brief Title
Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban
Acronym
ESPER
Official Title
Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
August 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.
Detailed Description
In 2011, 140 000 total hip replacements were performed and bleeding remains one of the major complications responsible for significant morbidity. This study will evaluate a new treatment to prevent bleeding due to this surgery. Indeed, the tranexamic acid (Exacyl) will be used in two modes of administration (standard or extended) versus placebo combined with a Rivaroxaban treatment at a dose of 10 mg / day for 35 days. Patients will be randomized (exacyl standard vs exacyl extended vs. placebo) and will be followed for 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss After a Total Hip Replacement
Keywords
Hip replacement, rivaroxaban, exacyl, blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Exacyl®: Standard treatment
Arm Type
Experimental
Arm Description
Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11
Arm Title
Group 2: Exacyl®: Extended treatment
Arm Type
Experimental
Arm Description
Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11
Arm Title
Group 3: Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11
Intervention Type
Drug
Intervention Name(s)
Exacyl®
Other Intervention Name(s)
Tranexamic acid
Intervention Type
Other
Intervention Name(s)
Placebo of Exacyl®
Primary Outcome Measure Information:
Title
Total blood loss
Description
Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht
Time Frame
Between Day-1of surgery and Day+3 of surgery (5 days)
Secondary Outcome Measure Information:
Title
Difference in haemoglobin level (g/dL) between Day-1 and Day+3
Time Frame
5 days
Title
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
Time Frame
5 days
Title
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
Time Frame
5 days
Title
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
Time Frame
3 month
Title
Surgical revision
Time Frame
3 month
Title
Occurrence of venous or arterial thromboembolic events
Time Frame
3 month
Title
Local infectious complications
Time Frame
3 month
Title
Death due to any cause and death due to cardiovascular cause
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years of age Scheduled to undergo elective non-traumatic primary cementless THA Having given written informed consent to participate in the trial Covered by Social Security Exclusion Criteria: Rapidly destructive arthrosis of the hip History of prior surgery on the operative hip Contraindications to the use of tranexamic acid: Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke) History of venous thromboembolism Severe renal impairment, i.e. with clearance < 30mL/mn Epilepsy or history of convulsions Contraindications to the use of rivaroxaban Severe renal failure (clearance <30ml / min) Cirrhotic patients with Child Pugh B Pregnancy and breastfeeding Cognitive disorder that precludes giving informed consent Refusal to participate in trial Allergy to either of the trial treatments On-going prophylaxis of thrombosis using an agent other than rivaroxaban On-going platelet aggregation inhibitor at a dose exceeding 125 mg daily
Facility Information:
Facility Name
HIA Clermont Tonnerre Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Polyclinique de Keraudren
City
Brest
ZIP/Postal Code
29287
Country
France
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CH Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France

12. IPD Sharing Statement

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Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban

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