Trial · NCT06617897
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with overall hemostatic success | During surgery to 24 hours after surgery | Overall hemostatic success will be assessed by an independent data monitoring and efficacy adjudication committee (IDMEAC). The IDMEAC will assess the overall efficacy based on a composite of intraoperative and postoperative hemostasis using a 4-point scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure). |
| Secondary | Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) | Up to 30 days after IV infusion | The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions. |
| Secondary | Number of participants with intraoperative hemostatic efficacy | During surgery | Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure). |
| Secondary | Number of participants with postoperative hemostatic efficacy | Up to 24 hours after surgery | Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure). |
| Secondary | Plasma fibrinogen concentration | During surgery, at the end of surgery and up to 24 hours after start of surgery | |
| Secondary | Mean total dose of fibrinogen administered | During surgery, at the end of surgery and up to 24 hours after start of surgery | |
| Secondary | Number of doses of fibrinogen administered | During surgery, at the end of surgery and up to 72 hours after start of surgery | |
| Secondary | Duration of surgery | During surgery | |
| Secondary | Intraoperative blood loss | During surgery | |
| Secondary | Intraoperative requirements for blood products | During surgery | Blood products include fresh frozen plasma, red blood cells, and platelets. |
| Secondary | Postoperative blood loss | Up to 48 hours after start of surgery | |
| Secondary | Postoperative requirements for blood products | Up to 9 days after surgery | Blood products include fresh frozen plasma, red blood cells, and platelets. |
| Secondary | Number of participants with reoperation (for bleeding) | Up to 30 days after surgery | |
| Secondary | Number of participants with reoperation (for reasons other than bleeding) | Up to 30 days after surgery | |
| Secondary | Duration of mechanical ventilation | Up to 30 days after surgery | |
| Secondary | Duration of intensive care unit (ICU) stay | Up to 30 days after surgery | |
| Secondary | Duration of hospital stay | Up to 30 days after surgery | |
| Secondary | 21-day mortality | Up to 21 days after surgery | |
| Secondary | In-hospital mortality | Up to 30 days after surgery | |
| Secondary | Time between placing the investigational product (IP) order to administration | During surgery | The following time to event parameters will be assessed: time between when IP is ordered and when IP is ready to administer in the operating room and time between when IP is ordered and start of IP administration. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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