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This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL511 | Experimental |
| |
| Cryoprecipitate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL511 Fibrinogen concentrate (human) | Biological | CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with overall hemostatic success | 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). | During surgery to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) | The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions. | Up to 30 days after IV infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | +1 610-878-4697 | clinicaltrials@cslbehring.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basingstoke and North Hampshire Hospital | Recruiting | Basingstoke | RG24 9NA | United Kingdom |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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| ID | Term |
|---|---|
| D000347 | Afibrinogenemia |
| D011553 | Pseudomyxoma Peritonei |
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
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| ID | Term |
|---|---|
| C026912 | cryoprecipitate coagulum |
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| Cryoprecipitate | Biological | Cryoprecipitate will be administered via IV infusion. |
|
| Number of participants with intraoperative hemostatic efficacy |
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). |
| During surgery |
| Number of participants with postoperative hemostatic efficacy | 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). | Up to 24 hours after surgery |
| Plasma fibrinogen concentration | During surgery, at the end of surgery and up to 24 hours after start of surgery |
| Mean total dose of fibrinogen administered | During surgery, at the end of surgery and up to 24 hours after start of surgery |
| Number of doses of fibrinogen administered | During surgery, at the end of surgery and up to 72 hours after start of surgery |
| Duration of surgery | During surgery |
| Intraoperative blood loss | During surgery |
| Intraoperative requirements for blood products | Blood products include fresh frozen plasma, red blood cells, and platelets. | During surgery |
| Postoperative blood loss | Up to 48 hours after start of surgery |
| Postoperative requirements for blood products | Blood products include fresh frozen plasma, red blood cells, and platelets. | Up to 9 days after surgery |
| Number of participants with reoperation (for bleeding) | Up to 30 days after surgery |
| Number of participants with reoperation (for reasons other than bleeding) | Up to 30 days after surgery |
| Duration of mechanical ventilation | Up to 30 days after surgery |
| Duration of intensive care unit (ICU) stay | Up to 30 days after surgery |
| Duration of hospital stay | Up to 30 days after surgery |
| 21-day mortality | Up to 21 days after surgery |
| In-hospital mortality | Up to 30 days after surgery |
| Time between placing the investigational product (IP) order to administration | 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. | During surgery |
| Prothrombin time and activated partial thromboplastin time | Up to 8 days after surgery |
| Coagulation parameter profile | The following coagulation parameter profiles will be assessed: thrombin generation marker, protein C and S, antithrombin and alpha 2-antiplasmin. | Up to 8 days after surgery |
| Coagulation factor profile | The following coagulation factor profiles will be assessed: fibrinogen, factor VIII (FVIII):C, von Willebrand ristocetin cofactor (VWF:Rco) and factor XIII (FXIII). | Up to 8 days after surgery |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |