NCT02640235: CELSTAT

Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

Completed NA Results posted Last updated 3 August 2020

What this trial tests

NA trial testing CELSTAT in Bleeding Active in 260 participants. Completed in 18 October 2017.

Timeline

24 February 2016

Primary endpoint
21 July 2017

18 October 2017

Quick facts

Lead sponsor	Baxter Healthcare Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	260
Start date	24 February 2016
Primary completion	21 July 2017
Estimated completion	18 October 2017
Sites	25 locations across United States, Germany, Poland, Czechia

Drugs / interventions tested

• CELSTAT
• Surgicel Original

Conditions studied

• Bleeding Active — all drugs for Bleeding Active →

Sponsor

Baxter Healthcare Corporation — full company profile →

Who can join

18 and older, any sex, with Bleeding Active. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application Primary · 5 minute (post-application)

Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.

Group	Value	95% CI
CELSTAT	94
Surgicel Original	109
CELSTAT	32
Surgicel Original	15

Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration Primary · Day 1 to Day 91

Findings are reported in this outcome measure and would have also been reported as an AE.

Group	Value	95% CI
CELSTAT	0
Surgicel Original	0

Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants Secondary · 0 to 10 minutes (post-application)

Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).

75% of Patients

Group	Value	95% CI
CELSTAT	6	3.25 – 7
Surgicel Original	4	3.17 – 5

50% of Patients

Group	Value	95% CI
CELSTAT	2	2 – 3
Surgicel Original	3	2 – 3

25% of Patients

Group	Value	95% CI
CELSTAT	0.833	0.58 – 1
Surgicel Original	1.292	0.83 – 2

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application Secondary · 3 minutes (post application)

The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

Group	Value	95% CI
CELSTAT	84
Surgicel Original	79
CELSTAT	42
Surgicel Original	45

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application Secondary · 7 minutes (post application)

The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

Group	Value	95% CI
CELSTAT	108
Surgicel Original	118
CELSTAT	18
Surgicel Original	6

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application Secondary · 10 minutes (post application)

The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

Group	Value	95% CI
CELSTAT	119
Surgicel Original	120
CELSTAT	7
Surgicel Original	4

Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis Secondary · 0 to 10 minutes (post-application)

If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."

Yes

Group	Value	95% CI
CELSTAT	3.3
Surgicel Original	2.5

No

Group	Value	95% CI
CELSTAT	96.7
Surgicel Original	97.5

Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) Secondary · Day 1 to Day 91

Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).

Group	Value	95% CI
CELSTAT	289
Surgicel Original	244

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to Day 101. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CELSTAT

Serious: 27/133 (20%)

Deaths: 2/133

Surgicel Original

Serious: 23/127 (18%)

Deaths: 3/127

Serious adverse events (52 terms)

Reaction	System	CELSTAT	Surgicel Original
Atrial Fibrillation	Cardiac disorders	—	—
Acute Myocardial Infarction	Cardiac disorders	—	—
Cellulitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Urinary Tract Infection	Infections and infestations	—	—
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	—	—
Vascular Graft Occlusion	Injury, poisoning and procedural complications	—	—
Wound Dehiscence	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Angina Pectoris	Cardiac disorders	—	—
Atrioventricular Block Complete	Cardiac disorders	—	—
Bradycardia	Cardiac disorders	—	—
Cardiac Arrest	Cardiac disorders	—	—
Cardiac Failure Congestive	Cardiac disorders	—	—
Pulseless Electrical Activity	Cardiac disorders	—	—
Supraventricular Tachycardia	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Enterovesical Fistula	Gastrointestinal disorders	—	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—	—
Chest Pain	General disorders	—	—
Impaired Healing	General disorders	—	—
Multi-Organ Failure	General disorders	—	—
Pyrexia	General disorders	—	—

Other adverse events (206 terms — click to expand)

Reaction	System	CELSTAT	Surgicel Original
Atrial Fibrillation	Cardiac disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Urinary Tract Infection	Infections and infestations	—	—
Procedural Hypotension	Injury, poisoning and procedural complications	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Hypertension	Vascular disorders	—	—
Chest Pain	General disorders	—	—
Anaemia Postoperative	Injury, poisoning and procedural complications	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Acute Kidney Injury	Renal and urinary disorders	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—
Tachycardia	Cardiac disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—	—
Oedema Peripheral	General disorders	—	—
Postoperative Ileus	Injury, poisoning and procedural complications	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Paraesthesia	Nervous system disorders	—	—
Urinary Retention	Renal and urinary disorders	—	—
Hypotension	Vascular disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Bradycardia	Cardiac disorders	—	—
Supraventricular Tachycardia	Cardiac disorders	—	—
Ventricular Tachycardia	Cardiac disorders	—	—
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	—	—
Impaired Gastric Emptying	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—
Drug Hypersensitivity	Immune system disorders	—	—
Bronchitis	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Postoperative Wound Infection	Infections and infestations	—	—

Most-reported serious reactions: Atrial Fibrillation, Acute Myocardial Infarction, Cellulitis, Pneumonia, Sepsis, Urinary Tract Infection, Post Procedural Haemorrhage, Vascular Graft Occlusion.

Data from ClinicalTrials.gov NCT02640235 adverse events section.

Sponsor's own description

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Application and outlook of topical hemostatic materials: a narrative review.
   Zhong Y, Hu H, Min N, Wei Y, et al · · 2021 · cited 71× · PMID 33987275 · DOI 10.21037/atm-20-7160
2. Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis.
   Beverly A, Ong G, Kimber C, Sandercock J, et al · · 2023 · cited 12× · PMID 36800489 · DOI 10.1002/14651858.cd013649.pub2