---
title: Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
nct_id: NCT01879475
overall_status: UNKNOWN
phase: NA
sponsor: Medtrade
study_type: INTERVENTIONAL
primary_condition: C.Surgical Procedure; Cardiac
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01879475.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01879475"
ct_last_update_post_date: 2015-04-07
last_seen_at: "2026-05-12T06:28:33.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

**Official Title:** Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.

**NCT ID:** [NCT01879475](https://clinicaltrials.gov/study/NCT01879475)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Medtrade
- **Collaborators:** The Clinical Trial Company
- **Conditions:** C.Surgical Procedure; Cardiac, Haemorrhage.
- **Start Date:** 2013-06
- **CT.gov Last Update:** 2015-04-07

## Brief Summary

The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* The patient must be equal or greater than 18 years old
* The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
* The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
* The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
* The patient must provide written informed consent using a form that is reviewed and approved by the IEC

Exclusion Criteria:

* The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
* The patient has a known hypersensitivity to materials of bovine origin
* The patient does not wish to receive materials of bovine or shellfish origin for any reason
```

## Arms

- **032-11** (EXPERIMENTAL) — 032-11 topical haemostat.
- **Floseal (R)** (ACTIVE_COMPARATOR) — Floseal(R) topical haemostat

## Interventions

- **032-11** (DEVICE) — Topical haemostat
- **Floseal (R)** (DEVICE) — Topical haemostat

## Primary Outcomes

- **Haemostasis success** _(time frame: Intra-operative)_ — Proportion of patients achieving haemostasis success following the first application of compression.

## Locations (1)

- Hull and East Yorkshire Hospitals NHS Trust, Hull, East Yorkshire, United Kingdom — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hull and east yorkshire hospitals nhs trust|hull|east yorkshire|united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01879475*  
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