Biliary Tract Surgical ProceduresPhase 4NCT00827931

Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

A Phase 4 study of Biliary Tract Surgical Procedures and Pancreaticoduodenectomy, run by Pfizer at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 2 sitesIndia
Study dates: Sep 2009to May 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

Who cannot join

Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
Patients with known coagulopathy.
Patients with anemia (hemoglobin levels less than 8 mg/dl)
Patients with documented DVT or PE at screening or in past three months.
Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

Trial locations and contacts

2 sites in 1 country.

India2 sites

Pfizer Investigational Site
Surat, Gujarat, 395 001
Pfizer Investigational Site
Vadodara, Gujarat, 390 001

Other trials in India

About this study

Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

Conditions: Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy
Being tested: Tranexamic acid + Standard of Care, Standard of Care
Keywords: tranexamic acid, major abdominal surgery, blood loss
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic acid + Standard of CareDrug
Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
Standard of CareProcedure or surgery
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Study groups in NCT00827931
Study group	Role	What they receive
A	Experimental	end of the operation and on the mornings of the first, second, fourth and seventh postoperative days. Receives: Drug: Tranexamic acid + Standard of Care
B	Other	Standard of Care Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-operative Blood Loss
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: Post-operation, Day 1, Day 2 up to drain removal

Secondary outcomes (6)

Intra-operative Blood Loss
Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: Day 1 (End of surgery)
Total Blood Loss
Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: Baseline through Day 2 post-surgery
Total Blood Loss as Assessed by the Gross' Formula
Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
Measured: Baseline through Day 2 post-surgery
Percentage of Participants Receiving Transfusions
A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.
Measured: Up to Day 7 post-surgery
Hemoglobin Levels
Measured: End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery
Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.
Measured: Day 7 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2011

First posted23 Jan 2009 (estimated)
Study startSep 2009
Primary completionApr 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Biliary Tract Surgical ProceduresStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00827931
Sponsor's protocol ID: B1461001
Status last verified: Apr 2012
First submitted: 22 Jan 2009
Last updated: 26 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Not yet recruiting
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
Cholelithiasis
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic

All Biliary Tract Surgical Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery
ClinicalTrials.gov ID: NCT00827931
Acronym / sponsor ID: B1461001
Conditions: Biliary Tract Surgical Procedures, Pancreaticoduodenectomy, Esophagectomy, Colectomy, Gastrectomy
Keywords: tranexamic acid, major abdominal surgery, blood loss
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Apr 2011 (actual)
Study completion: May 2011 (actual)
First posted: 23 Jan 2009 (estimated)
Results: Posted 26 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Tranexamic acid + Standard of Careend of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
B	Other	Procedure: Standard of CareStandard of Care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient undergoing major abdominal surgery (Biliary strictures, Pancreatico-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy, Other major abdominal surgeries with similar expected blood loss)

Key exclusion criteria (6 listed)

Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
Patients with known coagulopathy.
Patients with anemia (hemoglobin levels less than 8 mg/dl)
Patients with documented DVT or PE at screening or in past three months.
Patients with any associated major illness (e.g., severe cardiac or respiratory disease).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic acid + Standard of CareTranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)	Drug	A
Standard of CareStandard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss	Procedure or surgery	B

Primary outcome

Post-operative Blood Loss
Time frame: Post-operation, Day 1, Day 2 up to drain removal
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.

6 secondary outcomes

Intra-operative Blood Loss
Time frame: Day 1 (End of surgery)
Total Blood Loss
Time frame: Baseline through Day 2 post-surgery
Total Blood Loss as Assessed by the Gross' Formula
Time frame: Baseline through Day 2 post-surgery
Percentage of Participants Receiving Transfusions
Time frame: Up to Day 7 post-surgery
Hemoglobin Levels
Time frame: End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery
Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
Time frame: Day 7 post-surgery

Results and safety

Results posted to the registry on 26 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Acid Plus Standard of Care	49	43
Standard of Care	45	39

Primary outcome: Post-operative Blood Loss

Time frame: Post-operation, Day 1, Day 2 up to drain removal. Mean (Standard Deviation). Unit: milliliter (mL)

Measure	Tranexamic Acid Plus Standard of Care n = 23	Standard of Care n = 21
Value	394.3 (366.36)	494.3 (503.94)

Tranexamic Acid Plus Standard of Care vs Standard of Care: Mean Difference (Final Values): -99.9 (95% CI -371.4 to 171.5), p = 0.460, t-test, 2 sided

Population analysed: Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranexamic Acid Plus Standard of Care	9 of 49 (18.4%)	22 of 49 (44.9%)	Not reported
Standard of Care	7 of 45 (15.6%)	14 of 45 (31.1%)	Not reported

Limitations and caveats (from the sponsor): The intended FAS population was planned to include participants from 2 sites, however due to non-reliability of data from one of the sites, the actual FAS population included participants from a single site only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Biliary Tract Surgical Procedures

RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Not yet recruiting
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
Cholelithiasis
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Biliary Tract Surgical Procedures and Pancreaticoduodenectomy, run by Pfizer at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative Blood Loss (time frame: Post-operation, Day 1, Day 2 up to drain removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00827931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.