Trial · NCT01507896
BAX 326 Surgery Study in Hemophilia B Patients
NCT01507896, Phase 3, Completed, Baxalta now part of Shire; results first posted 2017-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BAX 326 Surgery Study in Hemophilia B Patients. Trials, record NCT01507896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01507896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BAX 326 Surgery Study in Hemophilia B Patients
- NCT number
- NCT01507896
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Hemophilia B
- Interventions
- Recombinant factor IX
- First posted
- 2012-01-11
- Last updated
- 2021-05-19
- Other registries' IDs
- eudract:2011-000413-39
- Results first posted
- 2017-02-15
- Limitations and caveats
- Data provided for surgical procedures, treatments with BAX326 etc. and for unique participants (one unique participant could undergo more than one surgical procedure).
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Hemostatic Efficacy | On day of surgery | Assessment by the operating surgeon on a 4 point ordinal scale (according to the definitions provided below): - Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% ) - Good: Intraoperative blood loss was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101 - 150%) - Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (\> 150%) - None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate |
| Primary | Actual Intraoperative Blood Loss | On day of surgery | Actual intraoperative blood loss was determined by the drainage volume, if a drain was placed, and the estimated blood loss into swabs and towels during the procedure. |
| Primary | Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon | On day of surgery | Predicted average/maximum blood loss minus actual blood loss. Prior to the surgery, the surgeon predicted the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study participant for the intraoperative period. |
| Primary | Postoperative Hemostatic Efficacy at Drain Removal | At drain removal (from 1-3 days postoperatively) | The postoperative hemostatic efficacy was to be assessed by the operating surgeon according to the following criteria (4-point ordinal scale): - Excellent: Volume in drain was less than or equal than that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% ) - Good: Volume in drain was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101% - 150%) - Fair: Volume in drain was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (\> 150%) - None: Uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate |
| Primary | Postoperative Hemostatic Efficacy at Postoperative Day 3 | At postoperative day 3 (approximately 72 hours postoperatively) | Assessment by the operating surgeon on a 4 point ordinal scale: - Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant - Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant - Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate - None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate |
| Primary | Postoperative Hemostatic Efficacy on Day of Discharge | At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | Assessment by the operating surgeon on a 4 point ordinal scale: - Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant - Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant - Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate - None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate |
| Primary | Actual Postoperative Blood Loss | At drain removal (from 1-3 days postoperatively) | Postoperative blood loss was based on the drainage fluid and was only assessed for participants who had a drain placed during surgery. |
| Primary | Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon | At postoperative day 3 (approximately 72 hours postoperatively) | Predicted average/maximum blood loss minus actual blood loss for participants who had a drain placed during surgery. Prior to the surgery, the surgeon will predict the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study subject for the postoperative period until drain removal. |
| Primary | Daily Weight-Adjusted Dose of BAX326 Per Participant | From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | Daily weight-adjusted doses of BAX326 per participant were recorded from the day of surgery until postoperative Days 11+. Each category in outcome measure includes number of all, major and minor surgeries, respectively, if different from the totals. |
| Primary | Total Weight-Adjusted Dose of BAX326 Per Participant | From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | Assessed for the intra- and postoperative periods. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraoperative Hemostatic Efficacy | On day of surgery | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 and had surgery. Note: a unique participant could have more than one surgical procedure. | surgeries | NUMBER |
| PRIMARY | Actual Intraoperative Blood Loss | On day of surgery | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure. Note: a unique participant could have more than one surgical procedure. | mL | MEAN |
| PRIMARY | Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon | On day of surgery | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure. Note: a unique participant could have more than one surgical procedure. | mL | MEAN |
| PRIMARY | Postoperative Hemostatic Efficacy at Drain Removal | At drain removal (from 1-3 days postoperatively) | Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only). Note: a unique participant could have more than one surgical procedure | major surgeries with drain placed | NUMBER |
| PRIMARY | Postoperative Hemostatic Efficacy at Postoperative Day 3 | At postoperative day 3 (approximately 72 hours postoperatively) | Participants in the Full Analysis Set who were provided with a hemostatic efficacy assessment by the operating surgeon at post operative day 3 where no drain was employed. Note: a unique participant could have more than one surgical procedure. | surgeries | NUMBER |
| PRIMARY | Postoperative Hemostatic Efficacy on Day of Discharge | At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure. Note: a unique participant could have more than one surgical procedure. | surgeries | NUMBER |
| PRIMARY | Actual Postoperative Blood Loss | At drain removal (from 1-3 days postoperatively) | Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only). Note: a unique participant could have more than one surgical procedure. | mL | MEAN |
| PRIMARY | Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon | At postoperative day 3 (approximately 72 hours postoperatively) | Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only). Note: a unique participant could have more than one surgical procedure. | mL | MEAN |
| PRIMARY | Daily Weight-Adjusted Dose of BAX326 Per Participant | From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure. Note: a unique participant could have more than one surgical procedure. | IU/kg | MEAN |
| PRIMARY | Total Weight-Adjusted Dose of BAX326 Per Participant | From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery) | All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure. Note: a unique participant could have more than one surgical procedure. | IU/kg | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraoperative Hemostatic Efficacy | All Surgeries | Excellent | 37 | surgeries | |
| Intraoperative Hemostatic Efficacy | Major Surgeries | Excellent | 20 | surgeries | |
| Intraoperative Hemostatic Efficacy | Minor Surgeries | Excellent | 17 | surgeries | |
| Intraoperative Hemostatic Efficacy | All Surgeries | Good | 1 | surgeries | |
| Intraoperative Hemostatic Efficacy | Major Surgeries | Good | 1 | surgeries | |
| Intraoperative Hemostatic Efficacy | Minor Surgeries | Good | 0 | surgeries | |
| Intraoperative Hemostatic Efficacy | All Surgeries | Fair | 0 | surgeries | |
| Intraoperative Hemostatic Efficacy | Major Surgeries | Fair | 0 | surgeries | |
| Intraoperative Hemostatic Efficacy | Minor Surgeries | Fair | 0 | surgeries | |
| Intraoperative Hemostatic Efficacy | All Surgeries | None | 0 | surgeries |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With BAX326 | 30 | |
| Overall Study | COMPLETED | Treatment With BAX326 | 28 | |
| Overall Study | NOT COMPLETED | Treatment With BAX326 | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | Post procedural swelling | Injury, poisoning and procedural complications | All Participants | 3 | 30 | |
| other | Procedural pain | Injury, poisoning and procedural complications | All Participants | 7 | 30 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | All Participants | 3 | 30 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | All Participants | 4 | 30 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 10 | 30 |
| Total, serious adverse events | All Participants | 0 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01507896
GET https://conductscience.org/api/trials/v1/NCT01507896/registered?page=2