Patients Undergoing Microvascular SurgeryNCT02808273
Use of Bemiparine as a Prophylactic Antithrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
An observational study of Patients Undergoing Microvascular Surgery, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Undergoing Microvascular Surgery
- What is being tested?
- Bemiparine
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2016to 12 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who will undergo Oral and Maxillofacial or Plastic surgery that require reconstruction with microvascular flap at Hospital Ramón y Cajal, Madrid. A group of 67 patients treated according to a protocol for prevention of postoperative deep venous thrombosis with Bemiparina that will be compared with data collected from a group of 134 patients previously treated with a similar protocol but enoxaparin as antithrombotic agent.
Who may be able to join
- Patients that will undergo reconstructive surgery for defects in any part of the body, especially in head and neck, after cancer, traumatic or infectious pathology, which will require the use of techniques of microsurgery.
- Patients who have given their informed consent
- Patients in which it has been decided to use thromboprophylaxis with bemiparina before proposing them to participate in the study.
Who cannot join
- Patients not eligible for repair through the use of free flaps, and therefore the use of Microsurgical techniques for vascular anastomosis
- Patients with an underlying pathology that may interfere to a clinically significant or contraindicated the use of Bemiparina, such as: serious hepatic or renal insufficiency, uncontrolled arterial hypertension, history of gastroduodenal, thrombocytopenia, nephrolithiasis or uretrolitiasis and vascular disease ulcer of choroid and retina.
- Refusal of the patient or their family members to participate in the study.
- Pregnancy and breastfeeding
- Known hypersensitivity to study drugs or any of its components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Bemiparine as a Prophylactic Antitrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction.
Read the detailed description
This is an observational post-authorization study on a group of patients undergoing microsurgery on the Oral and Maxillofacial Surgery and Plastic and Reconstructive Surgery Service at Ramon y Cajal Hospital, Madrid for processes that require reconstruction with a flap microvascular. A group of 67 patients treated according protocol postoperative prevention of deep vein thrombosis with Bemiparina will be compared with data collected retrospectively from a group of 134 patients treated previously with an earlier protocol with enoxaparin as main antithrombotic agent.
- Being tested
- Bemiparine
- Keywords
- Bemiparine, Antithrombotic microsurgery protocol, Comparative study, Anticoagulant microsurgery protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparineDrug
Also called Hibor (3500UI/0,2ml)
Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis
| Study group | Role | What they receive |
|---|---|---|
| Retrospective control | Patients who had received enoxaparine as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis | |
| Prospective Cohort | Patients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis Receives: Drug: Bemiparine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the use of Bemiparine, against Clexane as an antithrombotic agent
Incidence thrombotic complications and bleeding
Measured: 24 months
Secondary outcomes (2)
Incidence of deep vein thrombosis and pulmonary embolism
Measured: 24 months
Incidence of postsurgery hemorrhagic strokes with both drugs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start2 Feb 2016
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Microvascular SurgeryStudies 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Rovi Pharmaceuticals Laboratories
- Responsible party
- Sponsor
- Investigators
- Julio Acero Sanz, MD; PhD, Principal investigator, Ramon y Cajal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808273
- Sponsor's protocol ID
- FUN-BEM-2015-01
- Status last verified
- Feb 2018
- First submitted
- 4 Mar 2016
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bemiparine as a Prophylactic Antitrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
- ClinicalTrials.gov ID
- NCT02808273
- Acronym / sponsor ID
- FUN-BEM-2015-01
- Keywords
- Bemiparine, Antithrombotic microsurgery protocol, Comparative study, Anticoagulant microsurgery protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Rovi Pharmaceuticals Laboratories
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 21 Jun 2016 (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.
A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction.
Detailed description
This is an observational post-authorization study on a group of patients undergoing microsurgery on the Oral and Maxillofacial Surgery and Plastic and Reconstructive Surgery Service at Ramon y Cajal Hospital, Madrid for processes that require reconstruction with a flap microvascular. A group of 67 patients treated according protocol postoperative prevention of deep vein thrombosis with Bemiparina will be compared with data collected retrospectively from a group of 134 patients treated previously with an earlier protocol with enoxaparin as main antithrombotic agent.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective control | – | –Patients who had received enoxaparine as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis |
| Prospective Cohort | – | Drug: BemiparinePatients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who will undergo Oral and Maxillofacial or Plastic surgery that require reconstruction with microvascular flap at Hospital Ramón y Cajal, Madrid. A group of 67 patients treated according to a protocol for prevention of postoperative deep venous thrombosis with Bemiparina that will be compared with data collected from a group of 134 patients previously treated with a similar protocol but enoxaparin as antithrombotic agent.
Key inclusion criteria (3 listed)
- Patients that will undergo reconstructive surgery for defects in any part of the body, especially in head and neck, after cancer, traumatic or infectious pathology, which will require the use of techniques of microsurgery.
- Patients who have given their informed consent
- Patients in which it has been decided to use thromboprophylaxis with bemiparina before proposing them to participate in the study.
Key exclusion criteria (5 listed)
- Patients not eligible for repair through the use of free flaps, and therefore the use of Microsurgical techniques for vascular anastomosis
- Patients with an underlying pathology that may interfere to a clinically significant or contraindicated the use of Bemiparina, such as: serious hepatic or renal insufficiency, uncontrolled arterial hypertension, history of gastroduodenal, thrombocytopenia, nephrolithiasis or uretrolitiasis and vascular disease ulcer of choroid and retina.
- Refusal of the patient or their family members to participate in the study.
- Pregnancy and breastfeeding
- Known hypersensitivity to study drugs or any of its components
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 |
|---|---|---|
| BemiparineAlso: Hibor (3500UI/0,2ml)Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis | Drug | Prospective Cohort |
Primary outcome
To compare the use of Bemiparine, against Clexane as an antithrombotic agent
Time frame: 24 months
Incidence thrombotic complications and bleeding
2 secondary outcomes
Incidence of deep vein thrombosis and pulmonary embolism
Time frame: 24 months
Incidence of postsurgery hemorrhagic strokes with both drugs
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
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Postoperative Management of Patients Undergoing Head and Neck Microvascular Free Flap Reconstructive Surgery: is Admission to an Intensive Care Unit Necessary?
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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.
Julio Acero Sanz, MD; PhD principal investigator
Ramon y Cajal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Microvascular Surgery, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site 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 5 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: finished, as of the sponsor's last update on 11 Feb 2019. 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 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the use of Bemiparine, against Clexane as an antithrombotic agent (time frame: 24 months). 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 11 Feb 2019.