N/A
N=260
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Bleeding Active
Bottom Line
View on ClinicalTrials.gov: NCT02640235 ↗Enrolled (actual)
260
Serious AEs
19.2%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application — 94; 109; 32; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CELSTAT (Device); Surgicel Original (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application |
94; 109; 32; 15 | — |
| PRIMARY Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration |
0; 0 | — |
| SECONDARY Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants |
6; 4; 2; 3; 0.833; 1.292 | — |
| SECONDARY Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application |
84; 79; 42; 45 | — |
| SECONDARY Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application |
108; 118; 18; 6 | — |
| SECONDARY Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application |
119; 120; 7; 4 | — |
| SECONDARY Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis |
3.3; 2.5; 96.7; 97.5 | — |
| SECONDARY Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) |
289; 244 | — |
Summary
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
Eligibility Criteria
Inclusion Criteria
Preoperative
- Subject is undergoing planned cardiothoracic, general or vascular surgery
Intraoperative
- Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Exclusion Criteria
Preoperative
- Subject needs emergency surgery
- Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
- Subject will undergo neurological or ophthalmological surgery
- Subject will undergo urological or gynecological surgery
- Subject has congenital coagulation disorder
- Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
Intraoperative:
- Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
- Disseminated intravascular coagulopathy
Data sourced from ClinicalTrials.gov (NCT02640235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.