Hemostatic DisordersPhase 4ROTEM-2010NCT01919840
Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol
A Phase 4 study testing Group ROTEM and Group C in people with Hemostatic Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Main objective: Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostatic Disorders
- What is being tested?
- Group ROTEM and Group C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2011
- Phase
- Phase 4
- 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
- Male and female patients
- over 18 years
- undergoing cardiac surgery
- with cardiopulmonary bypass
- bleed excessively
- As it is not possible to predict in advance who will bleed, informed consent will be required for all patients over 18 who are to undergo cardiac surgery with CPB.
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- Will be randomized to either group
- Those patients with diffuse bleeding after protamine administration. and / or
- They bleed excessively after surgery. Are excessive bleeding criteria: the debit ≥ 300ml drains in the first hour; ≥ 250ml in the second hour or ≥ 150ml at any later time. Consider that the patient is bleeding excessively when the drains debit is <150ml.
Who cannot join
- Patients <18 years
- Extracorporeal circulation surgery
- Surgery with Mini extracorporeal circulation (MECC)
- Refuse to participate in the study.
About this study
Official title: Indicación de transfusión de Hemoderivados en el Postoperatorio de cirugía Cardiaca Tras la implantación de un Sistema de monitorización de la coagulación a la Cabecera Del Paciente: Tromboelastometría Versus Protocolo Habitual de transfusión
Main objective:
Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.
Read more
Design:
Prospective randomized controlled trial and single blinded.
Disease or disorder under study:
Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
Primary endpoint:
median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively.
Duration of treatment:
The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a 150ml / h).
- Conditions
- Hemostatic Disorders
- Being tested
- Group ROTEM, Group C
- Keywords
- hemostatic disorders, ardiac surgery, cardiopulmonary bypass
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ROTEMProcedure or surgery
10 min after administration of protamine, if there is a large diffuse microvascular bleeding or bleed excessively at the exit of surgery then will check an Intem, a Heptem a Extem and Fibtem.
If any of the determinations altered and the patient leaves still bleeding apply the proposed treatment algorithm for Rotem. 10 minutes after each treatment will take the test again indicated that treatment, to ensure that the defect has been corrected.
Group COther
10 min. after protamine administration, if there is a significant diffuse microvascular bleeding or when the patient departure from surgery if bleeds excessively will be a TCA and routed the following analytical results: prothrombin time, activated partial thromboplastin time, platelet count and fibrinogen.
If any of the determinations altered and the patient still bleeding, apply the standard protocol of the unit. 10 minutes after each treatment was performed new laboratory tests to analyze the result.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | • conventional protocol, volume replacement with massive bleeding. Receives: Other: Group C |
| Group ROTEM | Experimental | • Protocol according to the different tests to be performed with thromboelastography Receives: Procedure: Group ROTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
median transfusion of packed red cells per patient
Measured: 24 hours
Secondary outcomes (1)
rate transfusion of platelets pool and plasma pool
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Low recruitment after the expected time to finish the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostatic DisordersStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Paniagua, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919840
- Sponsor's protocol ID
- IIBSP-ROT-2010-15
- Acronym
- ROTEM-2010
- Status last verified
- Aug 2013
- First submitted
- 12 Apr 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicación de transfusión de Hemoderivados en el Postoperatorio de cirugía Cardiaca Tras la implantación de un Sistema de monitorización de la coagulación a la Cabecera Del Paciente: Tromboelastometría Versus Protocolo Habitual de transfusión
- ClinicalTrials.gov ID
- NCT01919840
- Acronym / sponsor ID
- ROTEM-2010 / IIBSP-ROT-2010-15
- Conditions
- Hemostatic Disorders
- Keywords
- hemostatic disorders, ardiac surgery, cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment after the expected time to finish the study
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Aug 2013 (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:
Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.
Design:
Prospective randomized controlled trial and single blinded.
Disease or disorder under study:
Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
Primary endpoint:
median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively.
Duration of treatment:
The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains <a 150ml / h).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Other: Group C• conventional protocol, volume replacement with massive bleeding. |
| Group ROTEM | Experimental | Procedure: Group ROTEM• Protocol according to the different tests to be performed with thromboelastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients
- over 18 years
- undergoing cardiac surgery
- with cardiopulmonary bypass
- bleed excessively
Key exclusion criteria (4 listed)
- Patients <18 years
- Extracorporeal circulation surgery
- Surgery with Mini extracorporeal circulation (MECC)
- Refuse to participate in the study.
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 |
|---|---|---|
| Group ROTEM10 min after administration of protamine, if there is a large diffuse microvascular bleeding or bleed excessively at the exit of surgery then will check an Intem, a Heptem a Extem and Fibtem. If any of the determinations altered and the patient leaves still bleeding apply the proposed treatment algorithm for Rotem. 10 minutes after each treatment will take the test again indicated that treatment, to ensure that the defect has been corrected. | Procedure or surgery | Group ROTEM |
| Group C10 min. after protamine administration, if there is a significant diffuse microvascular bleeding or when the patient departure from surgery if bleeds excessively will be a TCA and routed the following analytical results: prothrombin time, activated partial thromboplastin time, platelet count and fibrinogen. If any of the determinations altered and the patient still bleeding, apply the standard protocol of the unit. 10 minutes after each treatment was performed new laboratory tests to analyze the result. | Other | Group C |
Primary outcome
median transfusion of packed red cells per patient
Time frame: 24 hours
1 secondary outcome
rate transfusion of platelets pool and plasma pool
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Low recruitment after the expected time to finish the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
Pilar Paniagua, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group ROTEM and Group C in people with Hemostatic Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 9 inclusion and 4 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 9 Aug 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment after the expected time to finish the study). 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?
median transfusion of packed red cells per patient (time frame: 24 hours). 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 9 Aug 2013.