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NCT01230931
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
NA trial testing Vitagel in Fracture Fixation in 26 participants. Terminated before completion.
1 April 2012
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 October 2010 |
| Primary completion | 1 April 2012 |
| Estimated completion | 1 April 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vitagel
- Standard of care
Conditions studied
- Fracture Fixation — all drugs for Fracture Fixation →
- Intra-Articular Fractures — all drugs for Intra-Articular Fractures →
- Acetabulum — all drugs for Acetabulum →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
Adults 18 to 65, any sex, with Fracture Fixation or Intra-Articular Fractures. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Intra-operative Rate of Blood Volume Loss
Time frame: at the time of surgery
The amount of blood loss during the surgery as measured by cell saver and lap counts. The cell saver and lap count totals will be summed.
Sponsor's own description
The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01230931
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Related trials
Other recruiting trials for Fracture Fixation
Currently open trials in the same condition.
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Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
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- NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01230931 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 20 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01230931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing