A Phase 4 interventional study of Vasopressin in Blood Loss, Surgical, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
The main purpose of this study is to compare blood loss at the time of laparoscopic or robotically-assisted laparoscopic myomectomy when using different amounts of dilute vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus. Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic surgery; although very little is know about the optimal dosage and administration.
The investigators plan to perform a randomized clinical trial on patients scheduled for minimally invasive myomectomy. All patients will get the same overall amount of vasopressin. Patients will be assigned by chance to one of two groups: one group will receive higher volume of a more dilute vasopressin solution. The other group will receive a lower volume of a more concentrated solution. The investigators will collect information on operative blood loss and complications related to surgery.
All surgeons who enroll patients into our study are experienced laparoscopic surgeons who have performed at least 100 advanced laparoscopic procedures including hysterectomies and myomectomies. Briefly, our laparoscopic myomectomy technique is as follows: After gaining peritoneal access and placing visual and operative trocars, the surgical site is inspected carefully and fibroid locations identified. After informing the anesthesia team that vasopressin (from pharmaceutical company American Regent 20 units/ml) is about to be injected, the uterus is infiltrated with vasopressin.
Patients will be randomized one of two treatment groups pre-operatively on the day of surgery:
The procedure is done according to surgeon preference using various energy modalities such as monopolar or Harmonic Scalpel® (Ethicon Endo-Surgery, Cincinnati OH), for making the incision in the uterus. The fibroid is then removed from the uterus and examined. The incision is then closed in several layers with laparoscopic standard suturing technique, and hysterotomy site is generally covered with an adhesion barrier (Gynecare Interceed® (Ethicon Women's Health and Urology, Somerville NJ) or Seprafilm® slurry (Genzyme Biosurgery, Framingham MA)).
Blood Samples:
As per routine, preoperative blood samples to assess hematocrit levels will be taken no greater than 2 weeks prior to surgical date; if no preoperative laboratory studies have been obtained a sample will be drawn on the day of surgery. Postoperative blood samples to assess hematocrit will be taken no sooner than 4 hours after surgery for patients who are discharged the same day; for patients who are monitored overnight in hospital, the lab will be drawn on postoperative day #1.
Follow-up:
Patients will be followed for 8 weeks after surgery to assess for occurrence of any postoperative complication. A member of the team (health care worker such as research assistant who has been trained in HIPPA procedures) will be in charge of abstracting data from the medical records and entering this information into a study database.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 152 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Inclusion Criteria:
20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Drug: Vasopressin
20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).
Drug: Vasopressin
Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.
Also known as: Pitressin
Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.
Time frame: 5 minutes post-operatively
Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.
Time frame: 5 minutes post-operatively
Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = \[total suction canister volume\] - \[volume of irrigation used\] - \[volume of vasopressin solution injected /2\].
Time frame: 5 minutes post-operatively
Number of Participants With Peri-operative Complications
Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).
Time frame: 8 weeks postoperatively
Total Operation Time
Time from incision to end of surgery
Time frame: 5 minutes postoperatively
| Milestone | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Started | 76 | 76 |
| Completed | 76 | 76 |
| Not completed | 0 | 0 |
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.
| hematocrit percentage | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage | -4.4 ± 3.9 | -4.0 ± 3.2 |
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.
| millileters | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss | 106.2 ± 3.0 | 119 ± 3.2 |
To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = \[total suction canister volume\] - \[volume of irrigation used\] - \[volume of vasopressin solution injected /2\].
| millileters | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation | 178 ± 265 | 198 ± 232 |
Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).
| Participants | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Number of Participants With Peri-operative Complications | 9 | 10 |
Time from incision to end of surgery
| minutes | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin |
|---|---|---|
| Total Operation Time | 176.8 ± 82.09 | 165.5 ± 70.26 |
Collected over Adverse events data was collected for a period of 4 years, from the start of the study (July 2011), to completion of the study (June 2015). The time frame for reporting adverse events will be within 7 calendar days of the adverse event. Patients were assessed from the time of their initial consult to 8 weeks following surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Volume Dilute Vasopressin | — | 0/76 (0%) | 0/76 (0%) |
| Low Volume Dilute Vasopressin | — | 0/76 (0%) | 0/76 (0%) |
| Age, Categorical(Participants) | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 76 | 76 | 152 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin | Total |
|---|---|---|---|
| Mean | 37.39 ± 5.68 | 37.87 ± 7.11 | 37.49 ± 6.39 |
| Sex: Female, Male(Participants) | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin | Total |
|---|---|---|---|
| Female | 76 | 76 | 152 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | High Volume Dilute Vasopressin | Low Volume Dilute Vasopressin | Total |
|---|---|---|---|
| United States | 76 | 76 | 152 |
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