Long-term Oral Anticoagulant TherapyPhase 3BERTANCT00484822
Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study)
A Phase 3 study testing Bemiparina Sodica and Heparina Cálcica in people with Long-term Oral Anticoagulant Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 31 sites in Spain.
Trial summary
Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required. However, there is no consensus on the optimal management in these situations, and heparin bridging therapy is the current usual practice in these situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Oral Anticoagulant Therapy
- What is being tested?
- Bemiparina Sodica and Heparina Cálcica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 31 sitesSpain
- Study dates
- Feb 2007to May 2009
- Phase
- Phase 3
- 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
- Patients over 18 years who have given their informed consent to participate in the study.
- Patients receiving oral anticogulants during at least 3 months and who require outpatient surgery, laparoscopy surgery or invasive procedures
- Procedures must be performed from 8 am to 15 pm.
Who cannot join
- Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT>5 times the normal value established by the reference range of the local hospital laboratory).
- Patients who have shown thromboembolic events with an appropriate INR.
- Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- Patients with organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms).
- Patients with a history of heparin-induced thrombocytopenia.
- Patients with suspected inability/or inability to comply with treatment and/or complete the study.
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- Patients who are participating in another clinical trial or have been participated in the past 30 days.
- Patients with antithrombin deficit and C and S protein deficit
- Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
- Acute bacterial endocarditis or slow endocarditis.
- Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
- Patients with antiplatelet therapy
- Patients with mechanical cardiac valves in mitral position and body weight 90 Kg with/or bone mass index (BMI) > 30 or 50 kg
- Patients with Starr-Edwards valves.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Spain31 sites
Hospital General de Alicante
Alicante, Alicante, 03010
Hospital de La Ribera
Alzira, Valencia, 46600
Hospital Tries I Pujol
Badalona, Barcelona, 08916
Hospital Del Mar
Barcelona, Barcelona, 08003
Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau
Barcelona, Barcelona, 08025
Hospital Sagrado Corazón
Barcelona, Barcelona, 08029
Hospital Puerta Del Mar
Cadiz, Cadiz, 11009
Hospital Provincial de Castellón
Castellon, Castellón, 12002
Hospital General de Castellón
Castellon, Castellón, 12004
Hospital Virgen de Las Nieves
Granada, Granada, 18012
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Arnau de Vilanova
Lleida, Lleida, 25198
Hospital La Princesa
Madrid, Madrid, 28006
Hospital Mataró
Mataró, Barcelona, 08304
Hospital Morales Messeguer
Murcia, Murcia, 30008
Hospital Comarcal de Valdeorras
O Barco de Valdeorras, Ourense, 32300
Hospital Son Dureta
Palma de Mallorca, Palma de Mallorca, 07014
Hospitalson Llàtzer
Palma de Mallorca, Palma de Mallorca, 07198
HOSPITAL DE NAVARRA (Pamplona)
Pamplona, Navarre, 31008
Hospital Clínica Universitaria Pamplona
Pamplona, Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Joan Xxiii
Tarragona, Tarragona, 43007
Hospital Mútua Terrassa
Terrassa, BARCELONA, 08221
Hospital Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Hospital de Torrevieja
Torrevieja, Alicante, 03186
HOSPITAL TORTOSA (Verge de la Cinta)
Tortosa, Tarragona, 43500
HOSPITAL ARNAU DE VILANOVA(Valencia)
Valencia, Valencia, 46015
Hospital de La Plana
Villarreal, Castellón, 12540
Hospital Vinaroz
Vinaròs, Castellón, 12500
Hospital Clinico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Multicentric, Randomized, Controlled, Double-blind Clinical Trial to Assess Perioperative Bridging Therapy With Sodium Bemiparin vs Calcium Unfractionated Heparin in Invasive Procedures, Outpatient Surgery and Laparoscopy Surgery in Patients Receiving Long-term Oral Anticoagulant Therapy
Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required. However, there is no consensus on the optimal management in these situations, and heparin bridging therapy is the current usual practice in these situations. No large randomized, controlled clinical trials have been yet performed to evaluate the efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.
Read the detailed description
THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3,500 IU, for the peri-operative procedural management of patients requiring temporary interruption of oral anticoagulation therapy (OAT).
PRIMARY EFFICACY ENDPOINT: combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure.
PRIMARY SAFETY ENDPOINT: incidence of major bleeding within 10 days after the invasive procedure.
- Conditions
- Long-term Oral Anticoagulant Therapy
- Being tested
- Bemiparina Sodica, Heparina Cálcica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemiparina SodicaDrug
3.500 UI/día.
Heparina CálcicaDrug
10.000 UI/día.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brazo 1: Bemiparina Sódica 3.500 UI/día. Receives: Drug: Bemiparina Sodica |
| 2 | Placebo comparator | Brazo 2: Heparina Cálcica 10.000 UI/día. Receives: Drug: Heparina Cálcica |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2009 (estimated)
Why it stopped: The study has been halted prematurely due to a low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Oral Anticoagulant TherapyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Fontcuberta Boj Jordi, Dr., Study chair, Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484822
- Sponsor's protocol ID
- ACO-BEMI-01-2006
- Other IDs
- 2006-001862-17
- Acronym
- BERTA
- Status last verified
- Feb 2010
- First submitted
- 8 Jun 2007
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Controlled, Double-blind Clinical Trial to Assess Perioperative Bridging Therapy With Sodium Bemiparin vs Calcium Unfractionated Heparin in Invasive Procedures, Outpatient Surgery and Laparoscopy Surgery in Patients Receiving Long-term Oral Anticoagulant Therapy
- ClinicalTrials.gov ID
- NCT00484822
- Acronym / sponsor ID
- BERTA / ACO-BEMI-01-2006
- Conditions
- Long-term Oral Anticoagulant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been halted prematurely due to a low recruitment.
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- May 2009 (estimated)
- First posted
- 11 Jun 2007 (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.
Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required. However, there is no consensus on the optimal management in these situations, and heparin bridging therapy is the current usual practice in these situations. No large randomized, controlled clinical trials have been yet performed to evaluate the efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.
Detailed description
THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3,500 IU, for the peri-operative procedural management of patients requiring temporary interruption of oral anticoagulation therapy (OAT).
PRIMARY EFFICACY ENDPOINT: combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure.
PRIMARY SAFETY ENDPOINT: incidence of major bleeding within 10 days after the invasive procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bemiparina SodicaBrazo 1: Bemiparina Sódica 3.500 UI/día. |
| 2 | Placebo comparator | Drug: Heparina CálcicaBrazo 2: Heparina Cálcica 10.000 UI/día. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years who have given their informed consent to participate in the study.
- Patients receiving oral anticogulants during at least 3 months and who require outpatient surgery, laparoscopy surgery or invasive procedures
- Procedures must be performed from 8 am to 15 pm.
Key exclusion criteria (14 listed)
- Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT>5 times the normal value established by the reference range of the local hospital laboratory).
- Patients who have shown thromboembolic events with an appropriate INR.
- Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- Patients with organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms).
- Patients with a history of heparin-induced thrombocytopenia.
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 |
|---|---|---|
| Bemiparina Sodica3.500 UI/día. | Drug | 1 |
| Heparina Cálcica10.000 UI/día. | Drug | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The study has been halted prematurely due to a low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
Related trials for Long-term Oral Anticoagulant Therapy
RecruitingObservational study
The Association Between Non-vitamin K Antagonist Oral Anticoagulant Therapy and Acute Stroke Severity and Post Stroke Short-term and Long-term Outcomes.
Therapeutic Drug Monitoring
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.
Fontcuberta Boj Jordi, Dr. study chair
Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparina Sodica and Heparina Cálcica in people with Long-term Oral Anticoagulant Therapy, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 31 sites in Spain.
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 3 inclusion and 14 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: The study has been halted prematurely due to a low recruitment.). 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.
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 4 Feb 2010.