Trial · NCT01086852
Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery
NCT01086852, Phase 3, Terminated, Bio Products Laboratory; results first posted 2015-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery. Trials, record NCT01086852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01086852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery
- NCT number
- NCT01086852
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Bio Products Laboratory
- Conditions
- Factor X Deficiency
- Interventions
- FACTOR X
- First posted
- 2010-03-15
- Last updated
- 2019-02-05
- Results first posted
- 2015-07-03
- Limitations and caveats
- none reported
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Estimation of Volume of Blood Loss During Surgery | Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X. | As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count. The clinical assessment was rated as follows: * Blood loss less than expected * Blood loss as expected * Blood loss more than expected * Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery) |
| Primary | Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. | After wound closure | The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than. |
| Primary | Requirement for Blood Transfusion | during and after surgery | Number of blood transfusions required (units of packed red blood cells or units of whole blood) or infusion of autologous red cells during and after surgery |
| Primary | Number of Post Operative Bleeding Episodes (See Table Below) | End of surgery till end of study | Bleeding was assessed at least once each day by the investigator, more frequently if indicated by the severity of the operation or the subject's response. This included all bleeding episodes from the end of the surgical procedure until the subject was no longer at risk of bleeding due to surgery |
| Primary | Change of Haemoglobin From Pre-surgery Till End of Treatment | 2 hrs pre-operatively till end of treatment | The subject's haemoglobin was measured pre operatively, within 2 hours post operatively and at the End of Treatment Assessment. Changes in the subject's haemoglobin from pre to post operatively and from post operatively to the End of Treatment Assessment were assessed, taking into account the volume of fluid infused into the subject during the intervening periods, any blood transfusions in the intervening periods, the subject's haematocrit at the same time points and the subject's pre dose serum ferritin |
| Primary | Number of Participants With Degree of Bleeding Control Rated as Excellent. | During and till end of treatment | Investigators made an overall assessment of FACTOR X in controlling bleeding at the End of Treatment Assessment. The degree of bleeding control was rated as excellent, good, poor or unassessable, in accordance with the following criteria listed below: * Excellent -Parameters were similar to those in subjects without a bleeding disorder. * Good -Parameters were inferior to those in subjects without a bleeding disorder, but no other factor X containing agents were required to restore haemostasis. * Poor - Blood loss was excessive (defined as more than twice the pre defined amount that would be expected in a subject without a bleeding disorder for this type of surgery) and/or Haemostasis was not achieved and/or Additional factor X containing agents were required to restore haemostasis. * Unassessable -Efficacy was not possible to assess, or Additional factor X containing agents (excluding blood transfusions) were required before efficacy of FACTOR X could be assessed. |
| Secondary | Incremental Recovery After Bolus Dose of FACTOR X | incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus | Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value. Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg) |
| Secondary | Dose Per Infusion (IU/kg) | before surgery, during the post operative period | weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Estimation of Volume of Blood Loss During Surgery | Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X. | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | ml | GEOMETRIC_MEAN |
| SECONDARY | Incremental Recovery After Bolus Dose of FACTOR X | incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | IU/dL per IU/kg | GEOMETRIC_MEAN |
| PRIMARY | Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. | After wound closure | All subjects treated with FACTOR X | participants | NUMBER |
| PRIMARY | Requirement for Blood Transfusion | during and after surgery | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | number of transfusions | NUMBER |
| PRIMARY | Number of Post Operative Bleeding Episodes (See Table Below) | End of surgery till end of study | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | number of bleeds | NUMBER |
| PRIMARY | Change of Haemoglobin From Pre-surgery Till End of Treatment | 2 hrs pre-operatively till end of treatment | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | g/L | GEOMETRIC_MEAN |
| SECONDARY | Dose Per Infusion (IU/kg) | before surgery, during the post operative period | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | IU/kg | MEDIAN |
| PRIMARY | Number of Participants With Degree of Bleeding Control Rated as Excellent. | During and till end of treatment | The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Estimation of Volume of Blood Loss During Surgery | FACTOR X | 160.5 | Standard Deviation 168.49 | ml | |
| Incremental Recovery After Bolus Dose of FACTOR X | FACTOR X | 2.14 | Standard Deviation 0.224 | IU/dL per IU/kg | |
| Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. | Active Treatment With FACTOR X | Less Than | 1 | participants | |
| Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. | Active Treatment With FACTOR X | More Than | 0 | participants | |
| Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder. | Active Treatment With FACTOR X | Equal to | 3 | participants | |
| Requirement for Blood Transfusion | Active Treatment With FACTOR X | 0 | number of transfusions | ||
| Number of Post Operative Bleeding Episodes (See Table Below) | Active Treatment With FACTOR X | 0 | number of bleeds | ||
| Change of Haemoglobin From Pre-surgery Till End of Treatment | Active Treatment With FACTOR X | -36.0 | Standard Deviation 26.17 | g/L | |
| Dose Per Infusion (IU/kg) | Active Treatment With FACTOR X | 16.14 | Full Range 10.13 to 22.30 | IU/kg | |
| Number of Participants With Degree of Bleeding Control Rated as Excellent. | Active Treatment With FACTOR X | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Treatment With FACTOR X | 4 | |
| Overall Study | COMPLETED | Active Treatment With FACTOR X | 4 | |
| Overall Study | NOT COMPLETED | Active Treatment With FACTOR X | 0 |
Source ClinicalTrials.gov
Adverse events19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haematoma | Vascular disorders | FACTOR X | 1 | 4 | 1 |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | FACTOR X | 1 | 4 | 2 |
| other | Contusion | Injury, poisoning and procedural complications | FACTOR X | 1 | 4 | 1 |
| other | Incision site complication | Injury, poisoning and procedural complications | FACTOR X | 1 | 4 | 1 |
| other | Haemoglobin decreased | Investigations | FACTOR X | 1 | 4 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | FACTOR X | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | FACTOR X | 1 | 4 | 1 |
| other | Procedural pain | General disorders | FACTOR X | 2 | 4 | 2 |
| other | Oedema peripheral | General disorders | FACTOR X | 2 | 4 | 2 |
| other | Insomnia | Psychiatric disorders | FACTOR X | 1 | 4 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FACTOR X | ||
| Total, other adverse events | FACTOR X | 4 | 4 |
| Total, serious adverse events | FACTOR X | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01086852
GET https://conductscience.org/api/trials/v1/NCT01086852/registered