Coagulation Protein DisordersNCT01053169
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
An observational study of Coagulation Protein Disorders and Blood Loss, Surgical, run by CSL Behring at 6 sites in United Kingdom.
Trial summary
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- What is being tested?
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N and Fresh Frozen Plasma
- Type of treatment
- Injection or infusion
- How many people
- 445 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- May 2010to Jan 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coagulopathy due to liver disease or other conditions requiring correction of coagulopathy who require surgical or diagnostic intervention and patients experiencing acute bleeding perioperatively
Who may be able to join
- For all cohorts:
- •≥ 16 years of age
- Received treatment with:
- Beriplex® P/N
- or FFP and Beriplex® P/N (in subsequent order)
- or FFP only
Show all 15Show fewer
- INR and/or PT results available in connection with administration of Beriplex® P/N or FFP:
- within 3 hours directly before and after administration of Beriplex® P/N or FFP
- In case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products
- Cohort P (Prophylaxis Group):
- Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy
- Coagulopathy (INR > 1.4 and/or PT ≥ 3 sec of upper limit of normal [ULN])
- Any planned major or minimally invasive procedure, except liver transplantation
- Cohort T (Treatment Group):
- Acute perioperative bleeding (as assessed by the investigator)
Who cannot join
- Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
- Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Royal Blackburn Hospital
Blackburn
Blackpool
Blackpool, FY3 8NR
Addenbrokes
Cambridge, CB23 3RE
Royal Free Hospital
London
Derriford Hospital
Plymouth
Southhampton General Hospital
Southhampton
About this study
Official title: Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.
- Being tested
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Keywords
- Coagulopathy, Perioperative bleeding, Prothrombin complex, Liver disease
- Medical subject headings
- Coagulation Protein Disorders, Blood Loss, Surgical, Hemostatic Disorders, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beriplex® P/NBiological
Also called Prothrombin complex concentrate
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
Fresh Frozen Plasma (FFP) and Beriplex® P/NBiological
Also called Prothrombin Complex Concentrate
FFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis.
Fresh Frozen PlasmaOther
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis Cohort | Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention Receives: Biological: Beriplex® P/N; Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N; Other: Fresh Frozen Plasma | |
| Treatment Cohort | Patients experiencing acute bleeding perioperatively Receives: Biological: Beriplex® P/N; Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N; Other: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of stopping or preventing bleeding
Measured: Up to 24 hours after treatment
Secondary outcomes (7)
Transfusions required
Measured: Up to 24 hours after treatment
Clinical trigger for administration of the intervention
Measured: Up to 24 hours after treatment
Mortality
Measured: Up to 24 hours after treatment
International normalized ratio (INR)
Measured: From 3 hours before and up to 24 hours after treatment
Prothrombin time (PT)
Measured: From 3 hours before and up to 24 hours after treatment
Receipt of other blood products and /or hemostatic agents
Measured: Up to 24 hours after treatment
Vital signs
Measured: From 3 hours before and up to 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Protein DisordersStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Cross-sectional
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pratima Chowdary, MRCP, FRCPath, Principal investigator, The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053169
- Sponsor's protocol ID
- BE1116_5001
- Other IDs
- 1492
- Status last verified
- Oct 2017
- First submitted
- 20 Jan 2010
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)
- ClinicalTrials.gov ID
- NCT01053169
- Acronym / sponsor ID
- BE1116_5001
- Keywords
- Coagulopathy, Perioperative bleeding, Prothrombin complex, Liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Jan 2010 (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.
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis Cohort | – | Biological: Beriplex® P/N, Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N, Other: Fresh Frozen PlasmaPatients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention |
| Treatment Cohort | – | Biological: Beriplex® P/N, Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N, Other: Fresh Frozen PlasmaPatients experiencing acute bleeding perioperatively |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coagulopathy due to liver disease or other conditions requiring correction of coagulopathy who require surgical or diagnostic intervention and patients experiencing acute bleeding perioperatively
Key inclusion criteria (15 listed)
- •≥ 16 years of age
- Received treatment with:
- INR and/or PT results available in connection with administration of Beriplex® P/N or FFP:
- In case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products
- Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy
Key exclusion criteria (2 listed)
- Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
- Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)
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 |
|---|---|---|
| Beriplex® P/NAlso: Prothrombin complex concentrateIntravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis. | Biological | Prophylaxis Cohort, Treatment Cohort |
| Fresh Frozen Plasma (FFP) and Beriplex® P/NAlso: Prothrombin Complex ConcentrateFFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis. | Biological | Prophylaxis Cohort, Treatment Cohort |
| Fresh Frozen PlasmaIntravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis. | Other | Prophylaxis Cohort, Treatment Cohort |
Primary outcome
Adequacy of stopping or preventing bleeding
Time frame: Up to 24 hours after treatment
7 secondary outcomes
Transfusions required
Time frame: Up to 24 hours after treatment
Clinical trigger for administration of the intervention
Time frame: Up to 24 hours after treatment
Mortality
Time frame: Up to 24 hours after treatment
International normalized ratio (INR)
Time frame: From 3 hours before and up to 24 hours after treatment
Prothrombin time (PT)
Time frame: From 3 hours before and up to 24 hours after treatment
Receipt of other blood products and /or hemostatic agents
Time frame: Up to 24 hours after treatment
Vital signs
Time frame: From 3 hours before and up to 24 hours after treatment
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 3 Oct 2017.
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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.
Pratima Chowdary, MRCP, FRCPath principal investigator
The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Protein Disorders and Blood Loss, Surgical, run by CSL Behring at 6 sites in United Kingdom.
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 15 inclusion and 2 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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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?
Adequacy of stopping or preventing bleeding (time frame: Up to 24 hours after treatment). 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 3 Oct 2017.