CoagulationNCT04868214
Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies' PoC Coagulometer
An observational study of Coagulation, run by Sciema UG at 5 sites in 2 countries.
Trial summary
The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation
- What is being tested?
- coagulation measurements
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Apr 2021to 30 Oct 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients on rivaroxaban, apixaban, or edoxaban and healthy volunteers between the ages of 18 and 80 years old
Who may be able to join
- Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- Be 18- to 80-years-of-age, inclusive, at time of consent.
- Have suitable venous access for at least a single venipuncture.
- Healthy volunteers must: Not be on medication designed to alter the coagulation state of a patient (including anticoagulants, anticoagulant reversal agents, platelet inhibitors, NSAIDs and thrombolytics or "clot buster" drugs), except as specified for phase 3 of testing.
- Eligible patients on anticoagulants must: Have taken their prescribed anticoagulant regularly at least for a month prior to study participation for inclusion in phase 3 of testing
- Eligible patients on anticoagulants must: Have been on their anticoagulant therapy for at least one month.
Who cannot join
- Have any of the following findings at Study Enrollment (information will be collected via questionnaire): Positive pregnancy test (females); Drug- or alcohol abuse; Use of tobacco or nicotine-containing products within 3 months prior to screening
- Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.
- Have a history of unexplained syncope.
- Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery.
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- Have received any blood product or anticoagulant within 3 months prior to Screening.
Show all 17Show fewer
- Have donated blood or blood products within 3 months prior to Screening.
- Have a history of minor bleeding episodes (e.g., epistaxis, bruising or gingival bleeding) within 1 month prior to screening, or a long-standing history of such bleeding.
- If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
- Eligible patients on anticoagulants must not:
- Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions, other than the condition for which a DOAC was prescribed.
- Have a history of unexplained syncope.
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- Consume more than 5 cigarettes per day.
- If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Perosphere Technologies Inc.
Boynton Beach, Florida, 33437
Daryl Mootoo, 475-218-4600, d.mootoo@Perospheretech.com
- Recruiting
Perosphere Technologies Inc.
Danbury, Connecticut, 06811
Daryl Motoo, 475-218-4600, d.mootoo@Perospheretech.com
- Recruiting
Perosphere Technologies Inc.
Rockville, Maryland, 20850
Daryl Mootoo, 475-218-4600, d.mootoo@Perospheretech.com
- Recruiting
Perosphere Technologies Inc.
White Plains, New York, 10605
Daryl Mootoo, 475-218-4600, d.mootoo@Perospheretech.com
Germany1 site, 1 recruiting
- Recruiting
Pfuetzner Science and Health Institute GmbH
Mainz, Rhineland-Palatinate, 55128
Andreas Pfuetzner, Prof., +4961315884640, info@pfuetzner-mainz.com
Silvia Scherer, +4961315884640, info@pfuetzner-mainz.com
About this study
The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway, the Perosphere Technologies' PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes, including the Direct Oral Anticoagulants, DOACs (e.g. rivaroxaban, apixaban, and edoxaban), as well as the heparins (e.g. enoxaparin, a low molecular weight heparin, and unfractionated heparin). The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls, as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites.
- Conditions
- Coagulation
- Being tested
- coagulation measurements
- Keywords
- coagulation, Factor Xa
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulation measurementsDevice
peak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Clotting times measured on Perosphere Technologies´ PoC of patients on Xarelto, Eliquis or Lixiana
Measured: During the first/single study visit
Secondary outcomes (1)
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Measured: During the first/single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Collaborators
- Perosphere Technologies Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868214
- Sponsor's protocol ID
- CP-01-02-001
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies' PoC Coagulometer
- ClinicalTrials.gov ID
- NCT04868214
- Acronym / sponsor ID
- CP-01-02-001
- Conditions
- Coagulation
- Keywords
- coagulation, Factor Xa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Collaborators
- Perosphere Technologies Inc.
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 30 Apr 2021 (actual)
- 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.
The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway, the Perosphere Technologies' PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes, including the Direct Oral Anticoagulants, DOACs (e.g. rivaroxaban, apixaban, and edoxaban), as well as the heparins (e.g. enoxaparin, a low molecular weight heparin, and unfractionated heparin). The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls, as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients on rivaroxaban, apixaban, or edoxaban and healthy volunteers between the ages of 18 and 80 years old
Key inclusion criteria (6 listed)
- Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- Be 18- to 80-years-of-age, inclusive, at time of consent.
- Have suitable venous access for at least a single venipuncture.
- Healthy volunteers must: Not be on medication designed to alter the coagulation state of a patient (including anticoagulants, anticoagulant reversal agents, platelet inhibitors, NSAIDs and thrombolytics or "clot buster" drugs), except as specified for phase 3 of testing.
- Eligible patients on anticoagulants must: Have taken their prescribed anticoagulant regularly at least for a month prior to study participation for inclusion in phase 3 of testing
Key exclusion criteria (17 listed)
- Have any of the following findings at Study Enrollment (information will be collected via questionnaire): Positive pregnancy test (females); Drug- or alcohol abuse; Use of tobacco or nicotine-containing products within 3 months prior to screening
- Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.
- Have a history of unexplained syncope.
- Have a history within 6 months prior to Screening of major bleeding, trauma, surgical procedure of any type, or vaginal delivery.
- Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coagulation measurementspeak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana. | Device | – |
Primary outcome
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
Time frame: During the first/single study visit
Clotting times measured on Perosphere Technologies´ PoC of patients on Xarelto, Eliquis or Lixiana
1 secondary outcome
Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay
Time frame: During the first/single study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
Related trials for Coagulation
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation, run by Sciema UG at 5 sites in 2 countries.
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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Pfuetzner, Prof. (+4961315884640, info@pfuetzner-mainz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices (time frame: During the first/single study visit). 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 28 Sep 2023.