Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee SurgeryBLOODNCT01430273
Assessment of Blood Loss With a Point Of Care Device
An observational study of Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study targets CAD patients exposed to antiplatelelt mono/bitherapy who need planned or emergency knee/hip athroplasty. This innovative study will bring new insights on how works antiplatelet therapy during the perioperative period according to drug exposition and metabolizer profile. Patients ethnicity will be recorded and defined according to the place of birth of the participants and of their parents given the identification of the metabolizer profile with respect to the CYP 2C19*2 carriage. The analysis will bestratified according to ethnicity to avoid biases.
Who may be able to join
- ≥18 years
- Patient in antiplatelet monotherapy (aspirin or clopidogrel) or dual therapy (aspirin + clopidogrel / prasugrel / ticagrelor) in the context of secondary prevention after:
- acute coronary syndrome
- and / or intracoronary stenting
- Planned or urgent hip (gamma nail, total prosthesis or through DHS) or knee arthroplasty
- Informed consent of the participant
- Patient receiving a social security scheme or entitled
Who cannot join
- Polytrauma
- Anemia <9g/dL
- Indication for oral anticoagulation
- Pelvic fracture justifying complex surgery
- Ongoing or recent major bleeding or recent major surgery (< 3 weeks)
- Liver failure
Show all 10Show fewer
- Thrombopenia <80 000/µl
- Lack of health insurance
- Mental disability
- Participation to any other research protocol
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institute of cardiology - Pitié Salpêtrière Hospital
Paris, 75013
pôle Anesthesie -Réanimation- CHU Pitie -Salpetrière
Paris, 75013
CHU Toulouse - Hôpital de Rangueil - Anésthésie-Réanimation
Toulouse, 31403
About this study
Official title: Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy
Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy
Read the detailed description
Type of study : Prospective, non-interventional, multicenter registry Principal Investigator: Collet Jean-Philippe Rational: Discontinuation of antiplatelet therapy in patients with established coronary artery disease (CAD) has become an increasingly important concern given the risk of recurrent arterial event. Exaggerated concern about increased procedure-related bleeding remains the major factor for premature discontinuation of APT. Interruption modalities and their impact on perioperative bleeding has never been prospectively evaluated and it is accepted that the maximum duration of interruption should not exceed 5 days for Clopidogrel/Ticagrelor and 7 days for Prasugrel given the fact that the remaining antiplatelet effect of APT is observed in less than 50% of patients after 3 days of interruption. Resuming APT after the operation has never been studied and remains a complex situation during anticoagulation is often prescribed to prevent deep vein thrombosis further increasing perioperative bleeding.
Hypotheses: (i) the volume of perioperative blood loss is correlated to the degree of platelet inhibition. (ii) Clopidogrel metabolizer status as defined by genetic profile is also correlated to perioperative blood loss. (iii) Resuming antiplatelet therapy during the perioperative period is not associated with a significant recovery of the antiplatelet effect.
Primary endpoint: Perioperative (day 1-day 5) blood loss in mL assessed by NADLER \& Mercurial formula* and PRU (for patients under Clopidogrel/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline. Secondary objectives: (i) to evaluate the correlation between clopidogrel genetic metabolizer status** and perioperative blood loss. To evaluate antiplatelet pharmacodynamic response at discharge according to metabolizer status. Definition*Blood loss in mL of Red Blood Cell (RBC) = Compensated RBC Volume (1 Pack=150mL) + Non Compensated RBC Vol. (Total Blood Loss : Ht D-1-Ht D+5). *PRU=Platelet Reaction Unit. It is a specific measure of on-clopidogrel platelet reactivity. Cut-off value is for defining high-on clopidogrel platelet reactivity is 230. ARU=Aspirin Reaction Unit. It is a specific measure of on-aspirin platelet reactivity. Cutoff value to identify high on-aspirin platelet reactivity is 550. ***Clopidogrel Metabolizer Phenotype is defined according to the carriage of the loss/gain-of function allele 2C19*2-*8/*17 as follows: SM for slow metabolizer: (*2-*8/*2-*8) ; Ultrafast Metabolizer (FM): (*17/*17) ; Normal/intermediate (M): (wt/wt, wt/*17, *2-*8/*17 or *2-*8/wt)
Number of subjects : 200 patients
Study duration: Two years.
Study duration per subject: length of hospital stay with a maximum duration of 30 days.
- Conditions
- Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery
- Keywords
- Antiplatelet therapy, Surgery, Bleeding, Platelet aggregation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Planned hip or knee arthroplasty | Patients with planned hip or knee arthroplasty | |
| urgent hip or knee arthroplasty | Patients with hip or knee arthroplasty in emergency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline
Perioperative (day 1-day 5) blood loss in mL assessed by NADLER \& Mercuriali formula* and PRU/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline.
Measured: day 1- day 5
Secondary outcomes (2)
Evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss.
When the patient discharges of surgery department
Measured: up to 10 days
To evaluate clopidogrel and aspirin pharmacodynamic response at discharge according to metabolizer status.
When the patient discharges of surgery department
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionDec 2015
Why it stopped: recruiting centers do not have the patient potential
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- COLLET Jean-Philippe, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430273
- Sponsor's protocol ID
- NI10028
- Other IDs
- 2010-A01454-35
- Acronym
- BLOOD
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2011
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT01430273
- Acronym / sponsor ID
- BLOOD / NI10028
- Conditions
- Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery
- Keywords
- Antiplatelet therapy, Surgery, Bleeding, Platelet aggregation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting centers do not have the patient potential
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy
Detailed description
Type of study : Prospective, non-interventional, multicenter registry Principal Investigator: Collet Jean-Philippe Rational: Discontinuation of antiplatelet therapy in patients with established coronary artery disease (CAD) has become an increasingly important concern given the risk of recurrent arterial event. Exaggerated concern about increased procedure-related bleeding remains the major factor for premature discontinuation of APT. Interruption modalities and their impact on perioperative bleeding has never been prospectively evaluated and it is accepted that the maximum duration of interruption should not exceed 5 days for Clopidogrel/Ticagrelor and 7 days for Prasugrel given the fact that the remaining antiplatelet effect of APT is observed in less than 50% of patients after 3 days of interruption. Resuming APT after the operation has never been studied and remains a complex situation during anticoagulation is often prescribed to prevent deep vein thrombosis further increasing perioperative bleeding.
Hypotheses: (i) the volume of perioperative blood loss is correlated to the degree of platelet inhibition. (ii) Clopidogrel metabolizer status as defined by genetic profile is also correlated to perioperative blood loss. (iii) Resuming antiplatelet therapy during the perioperative period is not associated with a significant recovery of the antiplatelet effect.
Primary endpoint: Perioperative (day 1-day 5) blood loss in mL assessed by NADLER \& Mercurial formula* and PRU (for patients under Clopidogrel/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline. Secondary objectives: (i) to evaluate the correlation between clopidogrel genetic metabolizer status** and perioperative blood loss. To evaluate antiplatelet pharmacodynamic response at discharge according to metabolizer status. Definition*Blood loss in mL of Red Blood Cell (RBC) = Compensated RBC Volume (1 Pack=150mL) + Non Compensated RBC Vol. (Total Blood Loss : Ht D-1-Ht D+5). *PRU=Platelet Reaction Unit. It is a specific measure of on-clopidogrel platelet reactivity. Cut-off value is for defining high-on clopidogrel platelet reactivity is 230. ARU=Aspirin Reaction Unit. It is a specific measure of on-aspirin platelet reactivity. Cutoff value to identify high on-aspirin platelet reactivity is 550. ***Clopidogrel Metabolizer Phenotype is defined according to the carriage of the loss/gain-of function allele 2C19*2-*8/*17 as follows: SM for slow metabolizer: (*2-*8/*2-*8) ; Ultrafast Metabolizer (FM): (*17/*17) ; Normal/intermediate (M): (wt/wt, wt/*17, *2-*8/*17 or *2-*8/wt)
Number of subjects : 200 patients
Study duration: Two years.
Study duration per subject: length of hospital stay with a maximum duration of 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned hip or knee arthroplasty | – | –Patients with planned hip or knee arthroplasty |
| urgent hip or knee arthroplasty | – | –Patients with hip or knee arthroplasty in emergency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets CAD patients exposed to antiplatelelt mono/bitherapy who need planned or emergency knee/hip athroplasty. This innovative study will bring new insights on how works antiplatelet therapy during the perioperative period according to drug exposition and metabolizer profile. Patients ethnicity will be recorded and defined according to the place of birth of the participants and of their parents given the identification of the metabolizer profile with respect to the CYP 2C19*2 carriage. The analysis will bestratified according to ethnicity to avoid biases.
Key inclusion criteria (7 listed)
- ≥18 years
- Patient in antiplatelet monotherapy (aspirin or clopidogrel) or dual therapy (aspirin + clopidogrel / prasugrel / ticagrelor) in the context of secondary prevention after:
- Planned or urgent hip (gamma nail, total prosthesis or through DHS) or knee arthroplasty
- Informed consent of the participant
- Patient receiving a social security scheme or entitled
Key exclusion criteria (10 listed)
- Polytrauma
- Anemia <9g/dL
- Indication for oral anticoagulation
- Pelvic fracture justifying complex surgery
- Ongoing or recent major bleeding or recent major surgery (< 3 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline
Time frame: day 1- day 5
Perioperative (day 1-day 5) blood loss in mL assessed by NADLER \& Mercuriali formula* and PRU/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline.
2 secondary outcomes
Evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss.
Time frame: up to 10 days
To evaluate clopidogrel and aspirin pharmacodynamic response at discharge according to metabolizer status.
Time frame: up to 10 days
Results and safety
The study was stopped early (reason given: recruiting centers do not have the patient potential). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COLLET Jean-Philippe, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruiting centers do not have the patient potential). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU/ARU* as measured using the VerifyNow®P2Y12 and aspirin assays at baseline (time frame: day 1- day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.