Acquired Bleeding DisorderPhase 2NCT01601457
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Trauma, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acquired Bleeding Disorder, Trauma
- What is being tested?
- activated recombinant human factor VII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2002to Apr 2004
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
- Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume
Who cannot join
- A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
- Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
- Body weight exceeding 135 kg
- Cardiac arrest following trauma and prior to surgery
- Known congenital bleeding disorders
- Known pregnancy or positive pregnancy test at enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.
- Conditions
- Acquired Bleeding Disorder, Trauma
- Being tested
- activated recombinant human factor VII, placebo
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated recombinant human factor VIIDrug
90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
placeboDrug
Administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
| Study group | Role | What they receive |
|---|---|---|
| Activated recombinant human factor VII | Experimental | Not described Receives: Drug: activated recombinant human factor VII |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of perioperative blood loss
Secondary outcomes (4)
Volumes of intraoperative and postoperative blood loss
Volume of blood transfused during the perioperative period
Vital signs
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startSep 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601457
- Sponsor's protocol ID
- F7ORTHO-1506
- Status last verified
- Jan 2017
- First submitted
- 16 May 2012
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2005 May;94(5):586-91. doi: 10.1093/bja/aei102. Epub 2005 Feb 25.
PubMed 15734783Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
PubMed 18580208
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery
- ClinicalTrials.gov ID
- NCT01601457
- Acronym / sponsor ID
- F7ORTHO-1506
- Conditions
- Acquired Bleeding Disorder, Trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 18 May 2012 (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.
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated recombinant human factor VII | Experimental | Drug: activated recombinant human factor VII |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
- Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume
Key exclusion criteria (6 listed)
- A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
- Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
- Body weight exceeding 135 kg
- Cardiac arrest following trauma and prior to surgery
- Known congenital bleeding disorders
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 |
|---|---|---|
| activated recombinant human factor VII90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused | Drug | Activated recombinant human factor VII |
| placeboAdministered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused | Drug | Placebo |
Primary outcome
Total volume of perioperative blood loss
4 secondary outcomes
Volumes of intraoperative and postoperative blood loss
Volume of blood transfused during the perioperative period
Vital signs
Adverse events
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 13 Jan 2017.
- Results publication: PubMed 15734783Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2005 May;94(5):586-91. doi: 10.1093/bja/aei102. Epub 2005 Feb 25.
- Results publication: PubMed 18580208Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Acquired Bleeding Disorder
RecruitingObservational study
Longitudinal Cohort of Thrombosis and Hemostasis Diseases
Immune Thrombocytopenia, Thrombotic Thrombocytopenic Purpura
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing activated recombinant human factor VII in people with Acquired Bleeding Disorder and Trauma, run by Novo Nordisk A/S at 1 site 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 2 inclusion and 6 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 13 Jan 2017. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Total volume of perioperative blood loss. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601457, which also lists 2 linked publications.
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 13 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.