HemorrhageHD-ROTEMNCT03703323
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis
A study testing Rotative thromboelastometry analysis in people with Hemorrhage, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Rotative thromboelastometry analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2018to 21 Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- Hospitalized patient in reanimation unit or continuous monitoring for digestive hemorrhage before or immediately after digestive endoscopy
- Digestive hemorrhage diagnostic: melena and/or rectal bleeding and/or hematemesis
- Affiliation to the social security
- Have signed an informed consent
Who cannot join
- Pregnant or nursing woman
- Without digestive fibroscopy
- With an anticoagulant treatment
- With a congenital coagulopathy
- Decision of therapeutic limitation or moribund patient
- With a digestive hemorrhage after an hospitalisation in reanimation unit for an other reason
- Participation in an other study in previous 30 days
- Under trusteeship, guardianship or judicial safeguards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage
Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.
Read the detailed description
Standard technique of coagulation analysis (prothrombin ratio, activated partial thromboplastin time, fibrinogen and platelet count) do not provide to guide practitioner in reanimation of hemostatic patients in particular when coagulation defect preexisting to the digestive hemorrhage.
In this respect, the main objective of this study is to evaluate the interest of rotative thromboelastometry in the care of patient with digestive hemorrhage and its mortality impact.
- Conditions
- Hemorrhage
- Being tested
- Rotative thromboelastometry analysis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotative thromboelastometry analysisOther
Obtaining blood sample (one tube of blood)
| Study group | Role | What they receive |
|---|---|---|
| Rotative thromboelastometry analysis | Experimental | Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality. Receives: Other: Rotative thromboelastometry analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
28-day mortality rate
Measured: day 28
Secondary outcomes (3)
Fresh-frozen plasma
Number of fresh-frozen plasma used within the first 48 hours of the care
Measured: day 2
Length of stay
Lenght of stay in reanimation unit
Measured: day 28
Recurrent bleeding
recurrent bleeding within the first 48 hours
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start8 Oct 2018
- Primary completion8 Aug 2020
- Study completion21 Aug 2020
Why it stopped: pandemic situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703323
- Sponsor's protocol ID
- 2018-03-CHRMT
- Acronym
- HD-ROTEM
- Status last verified
- Jan 2021
- First submitted
- 9 Oct 2018
- Last updated
- 30 Nov 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage
- ClinicalTrials.gov ID
- NCT03703323
- Acronym / sponsor ID
- HD-ROTEM / 2018-03-CHRMT
- Conditions
- Hemorrhage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: pandemic situation
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 11 Oct 2018 (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.
Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.
Detailed description
Standard technique of coagulation analysis (prothrombin ratio, activated partial thromboplastin time, fibrinogen and platelet count) do not provide to guide practitioner in reanimation of hemostatic patients in particular when coagulation defect preexisting to the digestive hemorrhage.
In this respect, the main objective of this study is to evaluate the interest of rotative thromboelastometry in the care of patient with digestive hemorrhage and its mortality impact.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotative thromboelastometry analysis | Experimental | Other: Rotative thromboelastometry analysisEvaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patient in reanimation unit or continuous monitoring for digestive hemorrhage before or immediately after digestive endoscopy
- Digestive hemorrhage diagnostic: melena and/or rectal bleeding and/or hematemesis
- Affiliation to the social security
- Have signed an informed consent
Key exclusion criteria (8 listed)
- Pregnant or nursing woman
- Without digestive fibroscopy
- With an anticoagulant treatment
- With a congenital coagulopathy
- Decision of therapeutic limitation or moribund patient
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 |
|---|---|---|
| Rotative thromboelastometry analysisObtaining blood sample (one tube of blood) | Other | Rotative thromboelastometry analysis |
Primary outcome
Mortality
Time frame: day 28
28-day mortality rate
3 secondary outcomes
Fresh-frozen plasma
Time frame: day 2
Length of stay
Time frame: day 28
Recurrent bleeding
Time frame: Day 2
Results and safety
The study was stopped early (reason given: pandemic situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotative thromboelastometry analysis in people with Hemorrhage, run by Centre Hospitalier Régional Metz-Thionville at 1 site 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 4 inclusion and 8 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: pandemic situation). 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?
Mortality (time frame: day 28). 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 30 Nov 2021.