HemoptysisHEMOCANOPENCT04825158
Study of the Role of Hemostasis in Perioperative Anaphylaxis
An observational study of Hemoptysis and Perioperative Complication, run by University Hospital, Strasbourg, France.
Trial summary
Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hemoptysis, Perioperative Complication, Anaphylaxis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 9 Feb 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will focus on any adult patient with a suspected diagnosis of perioperative anaphylactic shock
Who may be able to join
- Patient, male or female, adult
- In the perioperative period
- In whom the diagnosis of anaphylactic shock is suggested
- Patient is giving his consent to participate in the study
Who cannot join
- Subject under legal protection
- Subject under guardianship or guardianship
- Anemia less than 7 g /dl at the time of inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction
- Conditions
- Hemoptysis, Perioperative Complication, Anaphylaxis
- Medical subject headings
- Hemoptysis, Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Measured: As soon as possible after onset of anaphylaxis
Platelet activation
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Measured: 1-2 hours after the onset of anaphylaxis
Platelet activation
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Measured: 24 hours after the onset of anaphylaxis
Platelet activation
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Measured: During the allergic workup (4-6 weeks after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion9 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825158
- Sponsor's protocol ID
- 8030
- Acronym
- HEMOCANOPE
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Hemostasis in Perioperative Anaphylaxis
- ClinicalTrials.gov ID
- NCT04825158
- Acronym / sponsor ID
- HEMOCANOPE / 8030
- Conditions
- Hemoptysis, Perioperative Complication, Anaphylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 9 Feb 2024 (estimated)
- First posted
- 1 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.
Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will focus on any adult patient with a suspected diagnosis of perioperative anaphylactic shock
Key inclusion criteria (4 listed)
- Patient, male or female, adult
- In the perioperative period
- In whom the diagnosis of anaphylactic shock is suggested
- Patient is giving his consent to participate in the study
Key exclusion criteria (3 listed)
- Subject under legal protection
- Subject under guardianship or guardianship
- Anemia less than 7 g /dl at the time of inclusion
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
Platelet activation
Time frame: As soon as possible after onset of anaphylaxis
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Platelet activation
Time frame: 1-2 hours after the onset of anaphylaxis
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Platelet activation
Time frame: 24 hours after the onset of anaphylaxis
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Platelet activation
Time frame: During the allergic workup (4-6 weeks after)
Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoptysis and Perioperative Complication, run by University Hospital, Strasbourg, 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 4 inclusion and 3 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Charles-Ambroise TACQUARD, PHD (+333 69 55 16 08, charlesambroise.tacquard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet activation (time frame: As soon as possible after onset of anaphylaxis). The study lists 4 primary outcomes in all. 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 1 Apr 2021.